Elective unilateral total knee replacement using continuous femoral nerve blockade versus conventional patient-controlled analgesia: perioperative patient management based on a multidisciplinary pathway

Hong Kong Med J 2014;20:45–51 | Number 1, February 2014 | Epub 11 Sep 2013
DOI: 10.12809/hkmj133899
© Hong Kong Academy of Medicine. CC BY-NC-ND 4.0
 
ORIGINAL ARTICLE
Elective unilateral total knee replacement using continuous femoral nerve blockade versus conventional patient-controlled analgesia: perioperative patient management based on a multidisciplinary pathway
Janet WS Wu, FHKCA, FHKAM (Anaesthesiology)1; YC Wong, FHKCOS2
1 Department of Anaesthesia, Yan Chai Hospital, Tsuen Wan, Hong Kong
2 Department of Orthopaedics and Traumatology, Yan Chai Hospital, Tsuen Wan, Hong Kong
 
Corresponding author: Dr JWS Wu (janetwuws@gmail.com)
Abstract
Objectives: To evaluate the effectiveness of our new multidisciplinary pathway for total knee replacement patients and compare outcomes after continuous femoral nerve blockade versus conventional patient-controlled analgesia for postoperative pain.
 
Design: Randomised controlled trial in a routine clinical setting.
 
Setting: Acute orthopaedic wards and operating theatres, Yan Chai Hospital, Hong Kong.
 
Patients: Sixty patients underwent elective unilateral total knee replacement under spinal anaesthesia from May 2009 to September 2011 and were randomly assigned to continuous femoral nerve blockade or conventional patient-controlled analgesia (30 patients in each group).
 
Main outcome measures: Quality of pain control was evaluated by pain scores at rest and during mobilisation, opioid consumption, frequency of side-effects, and patient satisfaction score. Rehabilitation progress was assessed according to the day of first starting weight-bearing exercise, day of independent walking in the ward with aid, Timed Up and Go test, and time elapsing till discharge. Surgical outcome was assessed by the Knee Society score 6 months after discharge, re-admissions, and occurrence of complications.
 
Results: Patients having continuous femoral nerve blockade tended to have less pain on movement and achieved earlier mobilisation than those having patient-controlled analgesia. The former group consumed less opioids, had fewer side-effects, and were more satisfied with their postoperative analgesia. Both groups showed an equally high degree of satisfaction with the new management pathway. Hospital stays, surgical outcomes, and frequency of complications were similar in the two groups.
 
Conclusion: Continuous femoral nerve blockade proved to be a feasible and better alternative mode of postoperative analgesia than our conventional patient-controlled analgesia. Our new multidisciplinary management pathway and multimodal analgesic regimen featuring the continuous femoral nerve blockade appeared beneficial to patients and effective in our clinical setting.
 
 
New knowledge added by this study
  • Levobupivacaine concentration as low as 0.08% provided adequate analgesia in our patients with minimal muscle weakness and mild numbness.
  • Co-ordinated pathways featuring the use of continuous femoral nerve blockade were effective and appreciated by our patients.
Implications for clinical practice or policy
  • Work is necessary to identify areas of improvement to shorten hospital stays and hasten recovery without compromising outcomes and wellbeing.
  • A multidisciplinary approach to total knee replacement patients can be applied to other surgical groups, for whom suitable studies should be conducted to investigate possible overall benefit.
 
Introduction
Total knee replacement (TKR) is commonly performed to reduce chronic pain and improve the functional state of patients suffering from degenerative disease. A favourable patient outcome depends very much on surgical technique, postoperative analgesia, and active mobilisation. All these require input from different specialties and carers,1 for which well-coordinated clinical pathways on postoperative management have been shown to reduce hospital costs and improve quality of life of patients.2 3 4 Postoperative analgesia is an essential part of every pathway.5 6 7 Choices for postoperative analgesia are many. They include conventional patient-controlled analgesia (PCA) and various neuraxial and peripheral nerve blocks.8 9 In our new pathway, we featured the use of continuous femoral nerve blockade (CFNB) against our conventional PCA, because CFNB was shown to provide better analgesia, reduce patient opioid consumption and resulting side-effects.8 10 Various institutions also reported faster achievement of discharge criteria,11 quicker mobilisation,12 and better recovery at 6-week postoperation.13 The use of CFNB, together with a multimodal analgesic regimen, can provide better postoperative pain relief and hasten the speed of rehabilitation and mobilisation while minimising the drug side-effects.14 15 16
 
Our new multidisciplinary pathway comprised the following:
1. Introduction of CFNB against the conventional PCA, plus a standardised multimodal analgesic regimen (including a combination of paracetamol and sustained release diclofenate [Appendix 1] on optimising acute postoperative pain control).
2. Aggressive physiotherapy with early mobilisation, starting on postoperative day (POD) 1.
3. Active early screening for deep vein thrombosis (DVT) by ultrasonography on PODs 4-5.
4. Monitoring and treatment for complications, ensuring patient safety and satisfaction.
 

Appendix 1. Multimodal analgesic regimen for elective total knee replacement patients during study period
 
Methods
This was a randomised controlled trial using a structured questionnaire and data retrieval forms, and was conducted in orthopaedic wards and operating theatres (OTs) in Yan Chai Hospital between May 2009 and September 2011. Prior approval from Kowloon West Cluster Ethics Committee was obtained. The target patients were those who underwent unilateral elective TKR under spinal anaesthesia (SA). Patients unable to communicate, had contra-indications to peripheral nerve blockade, receiving anticoagulation or DVT prophylaxis, and those eventually converted to general anaesthesia or having complicated revision surgery were excluded from the study. A sample size of 60 patients was calculated based on a Power Analysis and Sample Size calculator with a background pain score of 0.6 (6/10), an expected difference of 0.3 (3/10), an alpha of 0.05 (2-sided), and power of 0.8. These 60 patients were randomised to the CFNB and PCA groups (30 patients in each), using computer-generated random numbers. Subjects were divided into two groups (odd against even numbers generated by the computer). The case allocation was concealed in sealed envelopes and the mode of analgesia revealed to case anaesthetist and patient after the patient was included in the study. No blinding was feasible for ward doctors, nurses, and physiotherapists due to practical constraints (different machine types being placed by the bedside). All cases were managed according to our new multidisciplinary TKR pathway (Appendix 2) and multimodal analgesic regimen (Appendix 1). Data were extracted from the preoperative period till 6 months after discharge from hospital.
 

Appendix 2. Multimodal analgesic regimen + multidisciplinary protocol for patients undergoing total knee replacement during study period
 
For CFNB patients, the relevant catheter was inserted under nerve stimulation and ultrasound guidance, and before the performance of SA inside the OT a correct position was confirmed by the case anaesthetist with ice and ultrasound in the induction/ recovery room. A standardised bolus of 15 mL 0.5% levobupivacaine was injected after insertion of the CFNB catheter. Successful femoral nerve blockade was ensured by testing with ice before performance of SA. Patients were then started on a continuous infusion of 8 to 12 mL/h of 0.08% levobupivacaine postoperatively in the recovery area till POD 3 (4-day infusion regimen) when the catheter was removed (in the ward by an anaesthetist). Regarding the PCA patients, they were allowed intravenous morphine after the operation, starting in the recovery area.
 
Both CFNB and PCA groups were started on a standardised multimodal analgesic regimen (if not contra-indicated) that entailed paracetamol, sustained release diclofenate, opioids (codeine or morphine), and drugs to prevent the side-effects from these analgesics (Appendix 2).
 
Both patient groups received SA using a 25G Quincke spinal needle and local anaesthetics injected intrathecally to achieve a block of at least T10 for the surgery. Then they underwent TKR using a tourniquet which was inflated to pressures of 250 to 280 mm Hg before skin incision. The tourniquet was deflated after bandages were applied at the end of surgery. Cement was used in all cases. A drain was inserted using suction and reviewed by surgeons and ward nurses on POD 1 (during the surgeon’s morning round). At that round, decisions were made as to whether the drain could be safely removed, the patient was fit to go for X-ray, and undergo mobilisation in the ward on that day (under supervision of the physiotherapist). Thereafter, the physiotherapist assessed the patient’s fitness to step up the intensity of exercise in the ward and then in the gymnasium of the Department of Physiotherapy (without monitoring by a nurse). Until discharge, each patient’s pain intensity and complications were monitored closely by ward nurses and surgeons.
 
Routine ultrasound screening was performed on PODs 4-5 to detect the early occurrence of DVT. All patients had sequential leg compressors applied and started on early mobilisation postoperatively from POD 1 if possible (to prevent DVT).
 
Data were collected on the quality of pain control (pain scores on visual analogue scale [VAS] of 1-10 at rest and during mobilisation, supervised by physiotherapist), opioid consumption and the frequency of side-effects (by ward nurse and anaesthetist doing pain rounds twice per day), patient satisfaction score (VAS 1-10 on the quality of analgesia by the pain anaesthetist), and discontinuation of PCA or CFNB. The progress of rehabilitation (from the day of mobilisation and independent walking in the ward), the Timed Up and Go test (conducted by the physiotherapist), and surgical outcomes were also recorded. Surgical outcomes entailed Knee Society scores (assessed preoperatively, upon discharge, and then 6 weeks and 6 months after discharge), complications, re-admissions, and mortality (all assessed by orthopaedic surgeons). All data were analysed using the Statistical Package for the Social Sciences (Windows version 10.0; SPSS Inc, Chicago [IL], US), and outcome measures were compared using Student’s t tests and Chi squared tests.
 
Results
In all, 79 patients were recruited but 19 were excluded for various reasons (Box), and replacements were recruited using the permuted block technique. Eventually 30 patients each were recruited as the CFNB and PCA groups. Basic demographic data, intra-operative surgical and anaesthetic parameters in the two groups were similar (Table 1).
 

Box. Excluded cases and reasons for exclusion
 

Table 1. Basic demographics, and surgical and anaesthetic details of the continuous femoral nerve blockade (CFNB) and conventional patient-controlled anaesthesia (PCA) groups
 
Regarding the quality of pain control, the CFNB patients tended to have lower pain scores during mobilisation on PODs 1 and 2 than those in the PCA group (Table 2), but their pain scores at rest were similar. For the sake of comparison, opioid consumption of each patient was converted to equivalent dosages of intravenous morphine. On this basis, the CFNB group consumed significantly less opioid than the PCA group only on PODs 0-1 (P<0.05), but more opioid on POD 3 (Table 2). Fewer patients suffered from opioid side-effects in the CFNB than PCA group on all PODs (nausea and/or vomiting 27% vs 63%, and dizziness 17% vs 40%; P<0.05 for both; Table 3). Mild catheter site oozing and mild limb numbness were reported in about one third of the CFNB patients. Notably, non-steroidal anti-inflammatory drug (NSAID)–related complications were rare in both groups. Patients were more satisfied with the quality of pain control by CFNB than PCA (Table 4; P=0.05). More patients would use the same form of postoperative analgesia again for TKR in the CFNB than PCA group (67% vs 50%, respectively).
 

Table 2. Maximum pain scores at rest and during mobilisation, and opioid consumption of the continuous femoral nerve blockade (CFNB) and conventional patient-controlled anaesthesia (PCA) groups
 

Table 3. Opioid side-effects in the continuous femoral nerve blockade (CFNB) and conventional patient-controlled anaesthesia (PCA) groups
 

Table 4. Patients’ satisfaction score upon discharge from hospital of the continuous femoral nerve blockade (CFNB) and conventional patient-controlled anaesthesia (PCA) groups
 
Concerning rehabilitation, more CFNB than PCA patients started mobilisation on POD 1 (83% vs 50%, respectively, P=0.012; Table 5). The mean day of independent walking in the ward was also earlier (POD 6 vs 8; P=0.047). Significant dizziness, and nausea and vomiting were the main reasons for delayed early mobilisation in the PCA group. We were unable to draw conclusions for the Timed Up and Go test because of missing data (30%). No accidental fall, injury, or complaint was reported throughout the study period.
 

Table 5. Day of starting mobilisation of the continuous femoral nerve blockade (CFNB) and conventional patientcontrolled anaesthesia (PCA) groups
 
Regarding surgical outcomes, the mean duration of hospitalisation, in-hospital surgical complications (bleeding, DVT, sepsis, etc) and Knee Society score and functional score changes from the preoperative period till the 6-month follow-up were similar in both groups (Table 6). In all, DVT was detected in five patients (on PODs 4-5): three were in the PCA group (2 had a body mass index [BMI] of >36 kg/m2). There was no other known predisposing factor for DVT in either group, and no pulmonary embolism or mortality was reported. Surgical infection occurred in two patients (1 in each group), for which they underwent re-operation.
 
As to the efficiency of our new TKR pathway, introduction of CFNB analgesia caused only a minimal effect on case turnover, as such cases were sent to the OT earlier to allow prior performance of the CFNB that was tested in the recovery/induction area before the previous case ended. The mean waiting time pending transferral to the OT after CFNB insertion was 28 minutes, and the mean discharge time from the OT to the recovery area was 6 minutes. Performance of the nerve block entailed a mean time of 32 minutes (all performed or supervised by anaesthesia specialists). After the operation, however, the CFNB group remained significantly longer in the recovery area (62 vs 46 minutes, P=0.014). No major mishap and/or patient complication (accidental fall, chronic neuropathic pain, or mortality) was reported. Both groups reported equally high satisfaction scores for our new TKR pathway (>9/10, P=0.791; Table 4).
 

Table 6. Summary of surgical outcomes of the continuous femoral nerve blockade (CFNB) and conventional patient-controlled anaesthesia (PCA) groups
 
Discussion
For TKR patients, our results showed favourable analgesic outcomes with the use of CFNB as compared to conventional PCA. The former was associated with lower pain scores during mobilisation (not at rest) and reduced opioid consumption and corresponding side-effects, which agreed well with previous studies.8 12 A larger sample size or further addition of new analgesics to our current regimen may be necessary to reveal a statistically significant difference in pain scores. Significantly more patients were able to mobilise on POD 1 in the CFNB group, which achieved better patient morale, and a sense of control and satisfaction. Earlier mobilisation was made possible due to better analgesia by CFNB and its opioid-sparing effect caused fewer distressing side-effects (nausea, vomiting, and dizziness). However, there was possible unintended over-treatment with opioids in the CFNB group from PODs 2-3 (when pain intensity had dropped markedly). Modifications were considered either to reduce the standard opioid dosage or attempt earlier removal of the catheter (on POD 2 instead of 3) so as to facilitate earlier aggressive exercise in the physiotherapy gymnasium. On the contrary, the PCA patients were less satisfied with quality of pain control; most of their distress being due to opioid-related side-effects that hindered activation and interfered with mobilisation on POD 1. There may have been under-utilisation of opioids in both groups, because the patients choose not to activate for further morphine boluses to avoid nausea/vomiting and dizziness despite moderate pain; but the extent of this effect was not estimated. In about two thirds of patients in both groups, NSAIDs were prescribed and transient renal impairment on POD 4 warranted stopping them in a few instances. Routine monitoring of renal function on POD 3 was not indicated, given our limited period of NSAID prescription (4 days) and the low frequency of renal impairment on POD 4.
 
Rehabilitation appeared to be faster with CFNB. No accidental dislodgement of CFNB/PCA catheters or patient injury was reported during physiotherapy with the machines and catheters in situ. The PCA group started independent walking in the ward earlier than CFNB group was possibly due to unavailability of services during weekends and public holidays. This manpower limitation may have affected less than 10% of our subjects, and was overcome in the middle of the study, when surgeons allocated more TKRs to be performed earlier in the week to facilitate continued physiotherapy in the immediate postoperative period. Long-term outcomes were similar as reflected by knee score changes. Mobility and function were both improved. Most patients were taking only simple analgesics (eg paracetamol as required) for any residual pain.
 
In both groups, DVT occurred in a minority of cases, with a frequency similar to that usually encountered in our hospital (8-10%). All subjects were encouraged to mobilise early to minimise DVT and foot pumps were applied from POD 0; two patients in PCA group were extremely obese (BMI >36 kg/m2). In such patients, there may be co-existing obstructive sleep apnoea and cardiovascular problems that warrant intensive care unit monitoring. However, beds may not always be available for such elective cases, resulting in unwanted cancellations on the proposed day of surgery. The role of CFNB, SA, and multimodal analgesics appear essential in this situation, so as to facilitate opioid sparing and reduce respiratory depression in the general ward while providing safer and better analgesia than PCA morphine. With better co-ordination, CFNB can be safely used and removed with concomitant use of low-molecular-weight heparin in high-risk cases. After our study, local guidelines have evolved to offer such patients regional blocks together with anticoagulation.
 
The work logistics with the introduction of CFNB to our TKR patients were efficient and different carers co-ordinated well to minimise disturbance to OT turnover and ensure patient safety and comfort during the whole process of rehabilitation. Despite achieving earlier mobilisation, we were unable to attain hospital stays shorter than 13 to 14 days (our pre-study standard), which was mostly for social reasons including lack of home carers, proper assistance for safe rehabilitation at home, personnel to bring patients back for out-patient follow-up and physiotherapy. Further collaboration with occupational therapists and social workers and preoperative psychosocial preparation for patients and their families in the new pre-admission clinic are essential, with a view to reducing hospital stays while ensuring patient satisfaction and safety.
 
Sources of error
Selection bias may have occurred when 19 patients were excluded from the original sample and may not have had the same demographic profile as their replacements (Table 1). When assessing for pain and satisfaction scores, measurement bias may have ensued when different ward nurses, anaesthetists, and physiotherapists asked patients at different times despite all of them having been instructed to ask questions in the same way in Cantonese and using the same VAS for comparison. Reported pain scores may also be affected by other similar patients nearby, and the carers not blinded to the mode of patient analgesia. The effect of self-withholding of opioids due to undesirable side-effect was not estimated (in both groups). Recall bias can occur when patients are asked about their satisfaction with our TKR pathway, as some may have left hospital already and the anaesthetist could only call them for assessment after discharge. Complete blinding of investigators and assessors was not possible in our setting, as the PCA and CFNB machines had very different appearances and were mounted near the bedside to facilitate easier and safer clinical care of analgesia.
 
Acknowledgements
Special thanks to the many dedicated colleagues from the Department of Anaesthesia, Orthopaedics and Traumatology, nursing teams of both orthopaedic wards and operating theatres, Physiotherapy, Occupational Therapy, social workers and pre-admission clinic nurses and staff who put in much effort to improve our service delivery and quality to achieve better patient outcomes.
 
References
1. Ranawat CS, Ranawat AS, Mehta A. Total knee arthroplasty rehabilitation protocol: what makes the difference? J Arthroplasty 2003;18(3 Suppl 1):27S-30S. Crossref
2. Kim S, Losina E, Solomon DH, Wright J, Katz JN. Effectiveness of clinical pathways for total knee and total hip arthroplasty: literature review. J Arthroplasty 2003;18:69-74. Crossref
3. Yasunaga H, Tsuchiya K, Matsuyama Y, Ohe K. Analysis of factors affecting operating time, postoperative complications, and length of stay for total knee arthroplasty: nationwide web-based survey. J Orthop Sci 2009;14:10-6. Crossref
4. Larsen K, Sørensen OG, Hansen TB, Thomsen PB, Søballe K. Accelerated perioperative care and rehabilitation intervention for hip and knee replacement is effective: a randomized clinical trial involving 87 patients with 3 months of follow up. Acta Orthop 2008;79:149-59. Crossref
5. Department recommendation for pain control in total knee replacement (TKR) surgery (1/7/2010). Hong Kong: Department of Anaesthesia and Intensive Care, Tuen Mun Hospital; 2010.
6. Clinical pathway—total knee replacement. Jan 2009. Ontario, Canada: The Credit Valley Hospital; 2009.
7. Walter FL, Bass N, Bock G, Markel DC. Success of clinical pathways for total joint arthroplasty in a community hospital. Clin Orthop Relat Res 2007;457:133-7.
8. Paul JE, Arya A, Hurlburt L, et al. Femoral nerve block improves analgesia outcome in total knee replacement. Anesthesiology 2010;113:1144-62. Crossref
9. Chu CP, Yap JC, Chen PP, Hung HH. Postoperative outcome in Chinese patients having primary total knee arthroplasty under general anaesthesia/intravenous patient-controlled analgesia compared to spinal-epidural anaesthesia/analgesia. Hong Kong Med J 2006;12:442-7.
10. Chelly JE, Greger J, Gebhard R, et al. Continuous femoral blocks improve recovery and outcome of patients undergoing total knee arthroplasty. J Arthroplasty 2001;16:436-45.  Crossref
11. Ilfeld BM, Le LT, Meyer RS, et al. Ambulatory continuous femoral nerve blocks decrease time to discharge readiness after tricompartment total knee arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology 2008;108:703-13. Crossref
12. Ilfeld BM, Mariano ER, Girard PJ, et al. A multicenter, randomized, triple-masked, placebo-controlled trial of the effect of ambulatory continuous femoral nerve blocks on discharge readiness following total knee arthroplasty in patients on general orthopedic wards. Pain 2010;150:477-84. Crossref
13. Carli F, Clemente A, Asenjo JF, et al. Analgesia and functional outcome after total knee arthroplasty: periarticular infiltration vs continuous femoral nerve block. Br J Anaesth 2010;105:185-95. Crossref
14. Hebl JR, Dilger JA, Byer DE, et al. A pre-emptive multimodal pathway featuring peripheral nerve block improves perioperative outcomes after major orthopedic surgery. Reg Anesth Pain Med 2008;33:510-7. Crossref
15. Parvataneni HK, Shah VP, Howard H, Cole N, Ranawat AS, Ranawat CS. Controlling pain after total hip and knee arthroplasty using a multimodal protocol with local periarticular injections: a prospective randomized study. J Arthoplasty 2007;22(6 Suppl 2):33S-38S. Crossref
16. Fischer HB, Simanski CJ, Sharp C, et al. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia 2008;63:1105-23. Crossref

How can the R.E.N.A.L. nephrometry scoring system aid management of a solid renal mass?

Hong Kong Med J 2014;20:37–44 | Number 1, February 2014 | Epub 22 Jul 2013
DOI: 10.12809/hkmj133920
© Hong Kong Academy of Medicine. CC BY-NC-ND 4.0
 
ORIGINAL ARTICLE
How can the R.E.N.A.L. nephrometry scoring system aid management of a solid renal mass?
MH Wong, FHKAM (Surgery)1; KY Cho, FRCR2; KL Ho, FHKAM (Surgery)1; KW Wong, MRCS (Surgery)1; CT Lai, MRCS (Surgery)1; CM Man, MRCS (Surgery)1; MK Yiu, FHKAM (Surgery)1
1 Division of Urology, Department of Surgery, The University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong
2 Department of Radiology, The University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong
 
Corresponding author: Dr MH Wong (edwong56@gmail.com)
Abstract
Objectives: To investigate use of the R.E.N.A.L. nephrometry score in relation to the choice of treatment and postoperative complications for renal masses.
 
Design: Case series.
 
Setting: A tertiary referral hospital in Hong Kong.
 
Patients: Data of patients undergoing nephrectomy were collected retrospectively from a clinical database and analysed. A R.E.N.A.L. nephrometry score was allocated to each renal tumour by a blinded qualified radiologist, utilising computerised imaging systems. Patient demographics, choice of surgery (radical vs partial), and approaches (open vs minimally invasive) were analysed with respect to their R.E.N.A.L. score.
 
Results: In all, 74 patients were included during the study period, of which 38 underwent partial nephrectomy and 36 underwent radical nephrectomy. No differences between the groups were found with respect to patient demographics. There were significant differences between the partial and radical nephrectomy groups in terms of their mean nephrometry score (6.9 vs 9.3, P<0.001). The mean nephrometry sum was also significantly different in the open approach versus the minimally invasive approach in patients having partial nephrectomy (7.8 vs 6.0, P=0.001). There was no difference in the postoperative 90-day morbidity and mortality in the partial nephrectomy and radical nephrectomy groups.
 
Conclusions: The R.E.N.A.L. nephrometry score of a renal mass correlated significantly with our choice of surgery (partial vs radical) and our approach to surgery (open vs minimally invasive surgery), particularly in the partial nephrectomy group. It does not, however, correlate with postoperative complications. The nephrometry score provides a useful tool for objectively describing renal mass characteristics and enhancing better communication for the operative planning directed at renal masses.
 
 
New knowledge added by this study
  • We externally validated the use of the R.E.N.A.L. nephrometry scoring system to differentiate choice of surgery (radical vs partial nephrectomy) and approach (open vs minimally invasive), which was not shown in previous studies.
  • We are able to qualify the weighting of individual parameters of the R.E.N.A.L. nephrometry scoring system on decision-making.
Implications for clinical practice or policy
  • Application of R.E.N.A.L. nephrometry scoring preoperatively may be used as a guide to the complexity and choice of surgery in patients with small solid renal masses. It also serves as a tool for patient counselling, with reference to postoperative outcomes.
  • Widespread use of this score may act as communication tools among specialists, such that direct comparisons of data and study results can be achieved.
 
Introduction
The annual incidence of renal cell carcinoma (RCC) in Hong Kong has increased steadily over the past 10 years reaching a rate of 5.9 cases per 100 000 inhabitants.1 Surgical management remains the main treatment modality. With advances and ready availability of imaging, including screening by ultrasonography, more RCCs are diagnosed at an early stage (ie T1). The treatment modalities of these localised renal masses include radical nephrectomy or partial nephrectomy, in the form of an open or laparoscopic (with or without robotic-assisted) approach, as well as other form of ablative therapy. Several large, retrospective studies and the recently published European Organization for Research and Treatment of Cancer randomised trial2 have confirmed that the oncological outcomes of partial nephrectomy and radical nephrectomy are equivalent. The advantages of radical nephrectomy include better preservation of renal function and prevention of renal failure, lower cardiovascular morbidity, and better overall survival.3 Although nephron-sparing surgery has slightly higher complication rate compared with radical nephrectomy,4 most international guidelines recommend the former as the standard treatment for solitary renal tumours up to a diameter of 7 cm, whenever technically feasible.5 6 In the US population, utilisation of such techniques has recently been reported to be low, partly due to lack of technical advancements and publicity about possible adverse long-term consequences.7
 
Decisions on the choice of surgery mostly depend on the size and location of the tumour. Other external factors, such as the surgeon’s training, practice pattern, operating centre facilities, and hardware available, have a major impact on the choice of approaches and operation to be performed. In the presence of multiple treatment options, an objective way to describe the complexity of renal masses and to accurately assess the risks of postoperative complications is important for patient counselling and clinical decision-making. Scoring systems have therefore been developed and validated, and to date three are available for clinical use.8 9 10
 
Herein, we report our investigation into using the R.E.N.A.L. nephrometry score, as developed by Kutikov and Uzzo in 2009,8 and its relationship to the choice of treatment and postoperative complications.
 
Methods
Data about patients having renal tumours treated by total nephrectomy in Queen Mary Hospital during the period of January 2006 to December 2011 were retrieved retrospectively from a clinical database and analysed. Patients who had not had preoperative computed tomography and three-dimensional reconstruction (available in the Queen Mary Hospital radiological department) were excluded, so as to standardise the radiographic characteristic of the renal tumours under study. This involved allocating a R.E.N.A.L. nephrometry score to each renal tumour utilising computerised imaging systems (GE Advantage Workstations; General Electric Healthcare, US) by a blinded qualified radiologist. The R.E.N.A.L. score was described in 2009 and includes the assessment of tumour (R)adius (size at the maximal diameter), (E)xophytic/ endophytic properties, (N)earness of tumour to the collecting system or sinus, (A)nterior/posterior descriptor, and (L)ocation relative to polar lines. Standardised points (1-3 points per descriptor) were assigned onto each parameter, except the anterior or posterior component as originally described by Kutikov and Uzzo8 (Table 1). Radius was measured as the maximum diameter of the tumour in centimetres and points were allocated as 1 (≤4 cm), 2 (>4 but <7 cm), and 3 (≥7 cm). Exophytic/endophytic points assigned were 1 when 50% or more of the tumour was exophytic, 2 when less than 50% was exophytic, and 3 when it was entirely endophytic. For non-spherical or asymmetrically located tumours, the predominant feature on any axis (not just the axial or coronal axis) was considered with reference to the renal cortex. The N component was measured as the distance of the deepest portion of the tumour to the collecting system and points were allocated as 1 (≥7 mm), 2 (>4 but <7 mm), and 3 (invading, touching or within 4 mm). Anterior/posterior location of the tumour was designated as a non-numerical suffix that describes the location of the tumour with respect to the kidney midline plane as assessed on axial images. When the mass was located at the tip of the renal poles or lay on the coronal plane where a meaningful anterior or posterior designation was not possible, the suffix “x” was assigned. The location score was assigned as the position of the mass relative to polar lines. The polar line was assigned as the plane of the kidney above or below which the medial lip of parenchyma was interrupted by the renal sinus fat, vessels or the collecting system and best located in the coronal plane. Two polar lines were measured for each renal unit. The position of the renal tumour with respect to the polar lines was measured and a score allocated as described in Table 1. Nephrometry classes in terms of complexity were allocated as low (4-6), moderate (7-9), and high (10-12) based on the sum of scores allocated to each parameter. Patient demographics, including age, gender, preoperative renal function, and estimated glomerular filtration rate (eGFR) as calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations were logged.11 In addition, the American Society of Anesthesiologists (ASA) class,12 chronic kidney disease stage, mode of surgery (radical vs partial), approaches (open vs minimally invasive surgery [MIS]), and ischaemic time were analysed with respect to their R.E.N.A.L. score and classes. The 90-day postoperative morbidity and mortality were retrieved according to the Clavien-Dindo system.13 Continuous variables were analysed with Student’s t test and categorical variables by the Chi squared and Fisher’s exact tests. Any P value of <0.05 was taken as statistically significant. All data were analysed with the Statistical Package for the Social Sciences (Windows version 18.0; SPSS Inc, Chicago [IL], US).
 

Table 1. R.E.N.A.L. nephrometry scoring system8
 
Results
There were 74 patients included during this study period, of which 38 underwent partial nephrectomy (group 1) and 36 underwent radical nephrectomy (group 2). There were 41 males and 33 females. No statistical differences were found between the groups in terms of gender distribution, age, preoperative creatinine level, ASA class, or chronic kidney disease stage, although the mean eGFR was significantly lower in the radical nephrectomy group (65 vs 77 mL/min, P=0.039; Table 2). The final pathology of the majority of our patients was clear-cell RCC (n=52), and the remainder suffered from angiomyolipoma (n=10), oncocytoma (n=4), chromophobe RCC (n=3), and others (n=5). There were significant differences between the partial and radical nephrectomy groups in terms of their mean nephrometry score (6.9 vs 9.3, P<0.001). Individual parameters of the R.E.N.A.L. score in terms of radius (P<0.001), nearest to the collecting system (P<0.001), and locations relative to polar lines (P=0.017) were significantly different in the two groups, but there was no significant difference in terms of exophytic components or anterior/posterior location (Table 3).
 

Table 2. Basic demographics of partial nephrectomy and radical nephrectomy groups
 

Table 3. Association between choice of surgery with nephrometry score and individual parameters
 
Further analysis of the partial nephrectomy patients revealed that respective mean nephrometry scores of open versus MIS were 7.8 vs 6.0 (P=0.001), and in particular the nearest components were significantly different (P<0.001; Table 4). Such a difference was evident for the radical nephrectomy group. The overall 90-day morbidity in our study cohort was low, and included urinary leakage (n=1) and bleeding warranting embolisation (n=1) in the partial nephrectomy group, and intestinal obstruction (n=1) in the radical nephrectomy group. None of our patients received a postoperative transfusion. Mortality at 90 days in the radical nephrectomy group (n=1) was in a patient with metastatic RCC undergoing cytoreductive nephrectomy. There was no difference in postoperative 90-day morbidity and mortality between the two groups, even after stratification according to mean nephrometry score or with respect to different classes (Table 5). Ischaemic time was significantly higher for patients in higher nephrometry classes in the partial nephrectomy group (36 mins vs 51 mins vs 80 mins, P=0.008; Table 6); all three patients with high nephrometry scores underwent open surgery using cold ischaemia with ice sludge surface cooling, thus explaining the difference in ischaemic time.
 

Table 4. Comparisons of surgical approaches in partial nephrectomy in relation to nephrometry score
 

Table 5. Complications
 

Table 6. Operative parameters of partial nephrectomy stratified by nephrometry class
 
Discussion
The standard care of patients with a solid renal mass is excision. Partial nephrectomy has become the standard for T1a RCCs and more recent data support its use in larger tumours of up to 7 cm (ie T1b). Most internationally recognised guidelines support recourse to partial nephrectomy for T1a tumours whenever technically feasible,5 6 as data suggest comparable oncological outcomes with more favourable outcomes in terms of risk of renal failure warranting dialysis, cardiovascular morbidity, and even mortality. Approaches to the management of a solid renal mass include consideration of whether to remove the whole kidney or resect the tumour only and achieve a margin clear of pathology. Secondary consideration is given to the approach of the surgery, be it a traditional open one or MIS (purely laparoscopic or robotic-assisted laparoscopic). Although the latter is technically more demanding and has more postoperative complications (blood loss, recourse to transfusions, and urinary leakage), many high-volume centres show favourable results in experienced hand.14
 
Many factors contribute to the choice of surgery and mode of approach. They include hospital infrastructures and patient volume, experience and training history of the relevant surgeons, patient preference, and most importantly tumour characteristics. Traditionally, clinical decisions were based mostly on the first of these factors, resulting in heterogeneous clinical choices and operative results. Even when only tumour characteristics were taken into account, there was wide heterogeneity in definitions, such as centrality or hilar location, and makes direct comparison of results between studies difficult and impractical.
 
The concept of nephrometry was proposed as a tool to objectively assess the complexity of a solid renal mass. To date there are three studies of largely nephrometric systems. They are the R.E.N.A.L nephrometry score proposed by Kutikov and Uzzo in 2009,8 the preoperative aspects and dimensions used for an anatomical (PADUA) classification of renal tumours by Ficarra et al in 2009,9 and the C-index method proposed by Simmons et al in 2010.10 Most studies utilise the nephrometry scales in patients undergoing partial nephrectomy. The three methods made use of different parameters to assess the locations of the tumour in relation to various important structures of the kidney, and to predict the technical difficulty that might be encountered during nephron-sparing surgery of the target lesion. They have been reviewed as new tools that can guide surgical decision-making to improve academic reporting, risk assessment of complications, and prediction of functional outcomes.
 
The R.E.N.A.L. nephrometry score is one of the most studied scoring systems with numerous articles describing its use in clinical practice. The original description of the score was to set a standard reporting system, and its use suggested a relationship between renal mass anatomy, pathology, and prognosis.8 Assessments of inter-observer variability confirm their reproducibility and inter-observer agreement was robust across specialties and levels of training.15 16 17 18 Later studies showed that high R.E.N.A.L. scores were associated with higher major complication rates than those with intermediate or low scores.15 19 Moreover, multivariate analysis revealed that prolonged operating time and high-complexity nephrometry score category were independent predictors of major complications.19 Other reports demonstrated that the R.E.N.A.L. score correlated with both tumour grade (P<0.0001) and histology (P<0.0001), such that as tumour size increases there would be a greater probability of malignancy, including high-grade and clear-cell tumour on histology.20 21 Nomograms have been developed based on study results to preoperatively predict the likelihood of malignant and high-grade pathology of an enhancing renal mass,20 and such systems have been externally validated.22 Other studies have demonstrated the association of nephrometry scores with use of ischaemia in partial nephrectomy,15 warm ischaemia time,23 choice of surgery (partial vs radical nephrectomy),17 24 25 need of conversion to radical nephrectomy,23 changes in the percent functional volume preserved and perioperative functional decrease,26 long-term renal functional outcome following partial nephrectomy,27 and postoperative urinary leakage.28 In particular R.E.N.A.L. scores were higher in patients with partial nephrectomy who developed complications than in partial nephrectomy patients who did not (6.9 vs 6.0, P=0.02). No corresponding differences were found in patients having radical nephrectomy (P=0.99).29 Other studies investigating their applications on robotic partial nephrectomy have shown incongruent results. In one study, Mufarrij et al30 did not show the ability of this scoring system to predict perioperative outcomes in robotic-assisted partial nephrectomy. Others found significant correlations of the score with increased warm ischaemia time, blood loss, complications, and length of hospital stay31 32 in patients undergoing robotic and laparoscopic partial nephrectomy. Clinical application of such anatomical classification systems has gained popularity in selecting cases suitable for alternative treatment of small renal masses (such as by thermal ablation).33 Available data so far show more evidence to support the use of this scoring system to make treatment decision more objective for renal masses.34 35
 
The results of our study clearly demonstrate a positive correlation of R.E.N.A.L. scores with the choice of nephrectomy (partial vs radical), in terms of the total summed scores and individual parameters including radius (size), location nearest to the collecting system, and relationship to polar lines. These findings support the idea that clinical decisions based solely on the size of tumours are oversimplified and other anatomical factors should enter overall considerations. We did not find significant correlations for other individual parameters, such as exophytic components and anterior/posterior location. This was in contrast to a previous study which espoused the relevance of such components to the choice of ablative therapy (radiofrequency, cryoablation, or partial nephrectomy) as originally described by Kutikov and Uzzo.8 Another significant finding was the correlation between the score and the choice of approach in partial nephrectomy. It was shown that with an increase in mean nephrometry score or class, there was a trend towards choosing open rather than a MIS approach. This signifies that whenever partial nephrectomy is feasible, the open method is preferred for more complex tumours and that this practice can be based on an objective scoring system. However, this was not observed in our radical nephrectomy group, which echoed a previous study finding and like the original description aimed at partial nephrectomy (not radical nephrectomy). The significant correlation of R.E.N.A.L. class with ischaemic time may be useful to guide the choice of open approaches for partial nephrectomy in the presence of a renal tumour with a high score. This could facilitate the safe use of cold ischaemia so as to maximise preservation of renal function.
 
Our results were contrary to previous investigators reporting that the R.E.N.A.L. score was not associated with presence or severity of complications in both patient groups in terms of their mean score or class. This could be explained by the relatively low frequency of major complications in our study cohort (5.4%) and in the small sample size. With more prospective data available, we believe similar correlations of the score with the frequency of postoperative complications and perioperative outcomes would be revealed.
 
An inherent limitation of our study was that it was retrospective with respect to data collection and analysis. A second limitation was the exclusion of many patients due to unavailability of satisfactory quality images for the calculation of scores to make direct comparisons. A third limitation of the R.E.N.A.L. score per se was that the weight given to individual components contributed to the total score; numerical values were allocated arbitrarily and still await validation. Although ours is one of the few studies that demonstrate the association of this score and individual parameters on the choice of surgery rather than sole reliance on tumour size, we still have to define a single value in this scoring system below which we can confidently recommend partial nephrectomy. Moreover, other confounding factors such as the surgeon’s experience and learning curve data were not available for analysis, and may heavily influence clinical decisions.
 
Future directions of studies and clinical utilisation of such a scoring system will aim to define different weightings for individual components contributing to the total score. Other studies may aim at enhancing the reproducibility and predictability of such tools, so that direct comparison can be made with other centres. Are we doing better than eyeballing when managing a solid renal mass? Maybe we are, but the use of the nephrometry score will enhance communication, documentation, and education for the coming younger generation of urologists. Lately, Simmons et al36 have described the integration of the R.E.N.A.L. and C-index scoring systems as diameter-axial-polar nephrometry (DAP). Initial results demonstrate the DAP scoring system to be simpler, to decrease measurement error, to improve performance characteristic, to make interpretation easier, and to exhibit a clear association with volume loss and late function after partial nephrectomy. More mature data will allow us to choose the best tools for our patients.
 
Conclusions
The R.E.N.A.L. nephrometry score of a solid renal mass shows a significant association with our choice of surgery (partial vs radical) and our approach to surgery (open vs MIS), particularly in patients receiving partial nephrectomy. Its association with postoperative complications was not demonstrated in this study. The score provides a useful tool to define the character of a renal mass objectively, aid clinical decision-making, and enhance communication between professionals with respect to the management of solid renal masses.
 
References
1. Hospital Authority. Hong Kong Cancer Registry. Available from: http://www3.ha.org.hk/cancereg/statistics.html. Accessed Jun 2013.
2. Van Poppel H, Da Pozzo L, Albrecht W, et al. A prospective randomized EORTC intergroup phase 3 study comparing the oncologic outcome of elective nephron-sparing surgery and radical nephrectomy for low-stage renal cell carcinoma. Eur Urol 2011;59:543-52. Crossref
3. Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med 2004;351:1296-305. Crossref
4. Van Poppel H, Da Pozzo L, Albrecht W, et al. A prospective randomized EORTC intergroup phase 3 study comparing the complications of elective nephron-sparing surgery and radical nephrectomy for low-stage renal cell carcinoma. Eur Urol 2007;51:1606-15. Crossref
5. Ljungberg B, Cowan NC, Hanbury DC, et al. EAU guidelines on renal cell carcinoma: the 2010 update. Eur Urol 2010;58:398-406. Crossref
6. Campbell SC, Novick AC, Belldegrun A, et al. Guideline for management of the clinical T1 renal mass. J Urol 2009;182:1271-9. Crossref
7. Smaldone MC, Kutikov A, Egleston B, et al. Assessing performance trends in laparoscopic nephrectomy and nephron-sparing surgery for localized renal tumors. Urology 2012;80:286-92. Crossref
8. Kutikov A, Uzzo RG. The R.E.N.A.L. nephrometry score: a comprehensive standardized system for quantitating renal tumor size, location and depth. J Urol 2009;182:844-53. Crossref
9. Ficarra V, Novara G, Secco S, et al. Preoperative aspects and dimensions used for an anatomical (PADUA) classification of renal tumors in patients who are candidates for nephron-sparing surgery. Eur Urol 2009;56:786-93. Crossref
10. Simmons MN, Ching CB, Samplaski MK, Park CH, Gill IS. Kidney tumor location measurement using the C index method. J Urol 2010;183:1708-13. Crossref
11. Levey AS, Stevens LA, Schmid CH, et al. A new equation to estimate glomerular filtration rate. Ann Intern Med 2009;150:604-12. Crossref
12. American Society of Anesthesiologists. New classification of physical status. Anesthesiology 1963;24:111.
13. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205-13. Crossref
14. Gill IS, Kavoussi LR, Lane BR, et al. Comparison of 1,800 laparoscopic and open partial nephrectomies for single renal tumors. J Urol 2007;178:41-6. Crossref
15. Hew MN, Baseskioglu B, Barwari K, et al. Critical appraisal of the PADUA classification and assessment of the R.E.N.A.L. nephrometry score in patients undergoing partial nephrectomy. J Urol 2011;186:42-6. Crossref
16. Kolla SB, Spiess PE, Sexton WJ. Interobserver reliability of the RENAL nephrometry scoring system. Urology 2011;78:592-4. Crossref
17. Weight CJ, Atwell TD, Fazzio RT, et al. A multidisciplinary evaluation of inter-reviewer agreement of the nephrometry score and the prediction of long-term outcomes. J Urol 2011;186:1223-8. Crossref
18. Montag S, Waingankar N, Sadek MA, Rais-Bahrami S, Kavoussi LR, Vira MA. Reproducibility and fidelity of the R.E.N.A.L. nephrometry score. J Endourol 2011;25:1925-8. Crossref
19. Simhan J, Smaldone MC, Tsai KJ, et al. Objective measures of renal mass anatomic complexity predicts rates of major complications following partial nephrectomy. Eur Urol 2011;60:724-30. Crossref
20. Kutikov A, Smaldone MC, Egleston BL, et al. Anatomic features of enhancing renal masses predicts malignant and high-grade pathology: a preoperative nomogram using the RENAL nephrometry score. Eur Urol 2011;60:241-8. Crossref
21. Satasivam P, Sengupta S, Rajarubendra N, Chia PH, Munshey A, Bolton D. Renal lesions with low R.E.N.A.L nephrometry score are associated with more indolent renal cell carcinomas (RCCs) or benign histology: findings in an Australian cohort. BJU 2012;109 Suppl 3:44-7.
22. Wang HK, Zhu Y, Yao XD, et al. External validation of a nomogram using RENAL nephrometry score to predict high grade renal cell carcinoma. J Urol 2012;187:1555-60. Crossref
23. Long JA, Arnoux V, Fiard G, et al. External validation of the RENAL nephrometry score in renal tumours treated by partial nephrectomy. BJU Int 2013;111:233-9. Crossref
24. Satasivam P, Rajarubendra N, Chia PH, Munshey A, Sengupta S, Bolton D. Trends in the use of nephron-sparing surgery (NSS) at an Australian tertiary referral centre: an analysis of surgical decision-making using the R.E.N.A.L. nephrometry scoring system. BJU Int 2012;109:1341-4. Crossref
25. Broughton GJ, Clark PE, Barocas DA, et al. Tumour size, tumour complexity, and surgical approach are associated with nephrectomy type in small renal cortical tumours treated electively. BJU Int 2012;109:1607-13. Crossref
26. Simmons MN, Hillyer SP, Lee BH, Fergany AF, Kaouk J, Campbell SC. Nephrometry score is associated with volume loss and functional recovery after partial nephrectomy. J Urol 2012;188:39-44. Crossref
27. Cha EK, Ng CK, Jeun B, et al. Preoperative radiographic parameters predict long-term renal impairment following partial nephrectomy. World J Urol 2013;31:817-22. Crossref
28. Bruner B, Breau RH, Lohse CM, Leibovich BC, Blute ML. Renal nephrometry score is associated with urine leak after partial nephrectomy. BJU Int 2011;108:67-72. Crossref
29. Rosevear HM, Gellhaus PT, Lightfoot AJ, Kresowik TP, Joudi FN, Tracy CR. Utility of the RENAL nephrometry scoring system in the real world: predicting surgeon operative preference and complication risk. BJU Int 2012;109:700-5. Crossref
30. Mufarrij PW, Krane LS, Rajamahanty S, et al. Does nephrometry scoring of renal tumors predict outcomes in patients selected for robot-assisted partial nephrectomy? J Endourol 2011;25:1649-53. Crossref
31. White MA, Haber GP, Autorino R, et al. Outcomes of robotic partial nephrectomy for renal masses with nephrometry score of ≥7. Urology 2011;77:809-13. Crossref
32. Hayn MH, Schwaab T, Underwood W, Underood W, Kim HL. RENAL nephrometry score predicts surgical outcomes of laparoscopic partial nephrectomy. BJU Int 2011;108:876-81.
33. Reyes J, Canter D, Putnam S, et al. Thermal ablation of the small renal mass: case selection using the R.E.N.A.L-Nephrometry Score. Urol Oncol 2013;31:1292-7. Crossref
34. Canter D, Kutikov A, Manley B, et al. Utility of the R.E.N.A.L. nephrometry scoring system in objectifying treatment decision-making of the enhancing renal mass. Urology 2011;78:1089-94. Crossref
35. Tobert CM, Kahnoski RJ, Thompson DE, Anema JG, Kuntzman RS, Lane BR. RENAL nephrometry score predicts surgery type independent of individual surgeon’s use of nephron-sparing surgery. Urology 2012;80:157-61. Crossref
36. Simmons MN, Hillyer SP, Lee BH, Fergany AF, Kaouk J, Campbell SC. Diameter-axial-polar nephrometry: integration and optimization of R.E.N.A.L. and centrality index scoring systems. J Urol 2012;188:384-90. Crossref

Occlusion therapy in amblyopia: an experience from Hong Kong

Hong Kong Med J 2014;20:32–6 | Number 1, February 2014 | Epub 9 Jan 2014
DOI: 10.12809/hkmj133952
© Hong Kong Academy of Medicine. CC BY-NC-ND 4.0
 
ORIGINAL ARTICLE
Occlusion therapy in amblyopia: an experience from Hong Kong
Emily WH Tang, FRCSEd1; Brian CY Li, MB, ChB1; Ian YL Yeung, MRCS (Ed), MRCOphth1,2; Kenneth KW Li, FRCSEd1,2
1 Department of Ophthalmology, United Christian Hospital, Kwun Tong, Hong Kong
2 Eye Institute, LKS Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong
 
Corresponding author: Dr EWH Tang (etang@graduate.hku.hk)
Abstract
 
Objectives: To review the results of patching for amblyopia management in Hong Kong.
 
Design: Retrospective case series.
 
Setting: Regional hospital, Hong Kong.
 
Patients: Records of all patients attending Paediatric Ophthalmology Clinic at United Christian Hospital, Hong Kong from 1 January 2009 to 31 March 2009 were retrospectively reviewed. Records of all children who underwent patching for amblyopia in the study period were evaluated.
 
Results: The mean age of 50 children (50 eyes) was 4 (standard deviation, 1; range, 2-7) years and mean pretreatment visual acuity was 0.35 (0.15; 0.02-0.63) [~20/60]. The values for mean, standard deviation, and range of treatment duration were 27, 16, 4-67 months respectively, and corresponding values for prescribed patching per day were 4, 1, 2-8 hours. The mean, standard deviation, and range of visual acuity at final post-treatment assessment were 0.66, 0.16, 0.1-1.0 (~20/30), respectively. The overall success rate (ie final visual acuity >0.7 or 20/30) was 62%. Children with moderate amblyopia (20/40-20/80) and severe amblyopia (20/100-20/400) had success rates of 74% and 55%, respectively. The mean visual acuity improvements for moderate and severely amblyopic children were 2.3 lines and 5.8 lines, respectively. The mean, standard deviation, and range of patching prescriptions for moderate and severely amblyopic children were 5, 1, 2-7 hours and 5, 1, 3-6 hours, respectively. Recurrence ensued in 7% of the children with moderate amblyopia and 46% of those with severe amblyopia. Reported compliance was good (>75% of the time) in 68% of the children.
 
Conclusion: Occlusion therapy is the mainstay of treatment in Hong Kong. The overall success rate was comparable to that achieved in the Amblyopia Treatment Study. Recurrence was more common in patients with severe amblyopia, for whom maintenance therapy may reduce the risk of recurrence. The duration of treatment was much longer in our locality than in western countries. Reported compliance was suspicious possibly due to traditional cultural contexts. It is important to emphasise compliance to all parents.
 
 
New knowledge added by this study
  • The Amblyopia Treatment Study (ATS) result cannot be directly applied to Hong Kong children. Heavier dosage for moderate amblyopia and longer treatment for both moderate and severe amblyopia appear necessary for successful treatment of affected Hong Kong children.
Implications for clinical practice or policy
  • The current practice for occlusion therapy in Hong Kong should not be changed to ATS recommendations; maintenance therapy should be considered with a view to reducing recurrences in children with severe amblyopia (visual acuity 20/100 to 20/400).
 
Introduction
Amblyopia is the most common cause of monocular visual impairment in both children and young adults.1 2 Since year 2002, the Pediatric Eye Disease Investigator Group has undertaken various randomised controlled trials, known as the Amblyopia Treatment Study (ATS). The ATS has provided insights into how amblyopia can be most effectively managed with respect to aspects such as dose response, the required amount of prescribed occlusion, compliance with treatment, use of atropine, and the upper age limit for treatment.3 4 5 6
 
Despite recent research on amblyopia treatment, studies show that the uptake of ATS guidelines and their results into clinical practice are sporadic and incomplete in both the UK and the US.7 Apparently, one third of paediatric ophthalmologists have made no changes whatsoever to their practice. Other studies found that 55% of paediatric ophthalmologists had decreased their prescribed patching regimens, which was contrary to ATS recommendations.8 9
 
In Hong Kong, patching is still the mainstay of treatment for unilateral amblyopia. Yet, the impact of the ATS guidelines on clinical practice is also inadequate. In our locality, prescriptions for patching are usually based on the age of the child. The duration and subsequent dosages are tapered or adjusted according to the individual child’s response and visual acuity (VA) improvement. Our study therefore aimed to compare current amblyopia management and results of patching at a government hospital in Hong Kong against the guidelines and results reported in the ATS.
 
Methods
This was a retrospective case series study, for which approval was obtained from the local research ethics committee. Records of all children attending the Paediatric Ophthalmology Clinic at the United Christian Hospital, Hong Kong from 1 January 2009 to 31 March 2009 were reviewed. All children who had received patching for amblyopia were identified. Two patients with structural abnormalities due to cataract and retinal pathologies, one with bilateral amblyopia warranting alternating patching, and three others with incomplete data or follow-up of less than 3 months were excluded. In all, 50 patients (50 eyes) were therefore identified and relevant demographic data were obtained.
 
Patching protocol
Visual acuity was measured using Sheridan Gardiner test for patients aged under 4 years and Snellen charts for those 4 years old or older. Optical correction was provided for all patients before commencement of patching. Refraction with or without cycloplegia was performed for the optical correction, which followed our departmental guidelines, at the discretion of the attending optometrist. Children were deemed to require cycloplegic refraction if they had unreliable retinoscopy or autorefraction readings (the very young, the uncooperative, or having pseudomyopia); accommodative esotropia; extreme refractive errors (especially myopia); anisometropia (>2 dioptres); or suspected amblyopia with >3 lines of difference in VA.
 
Prescription of patching was based on the age of the child, and the number of hours per day corresponded to the age. For instance, 3 hours per day for a 3-year-old and 5 hours per day for a 5-year-old. Patching duration was titrated according to the patient’s response and improvement of VA. Patching therapy was stopped when the best-corrected visual acuity (BCVA) of the amblyopic eye caught up or equalled that of the fellow eye, or when the patient reached 8 years old. Maintenance therapy was given to patients with severe pretreatment amblyopia after successful patching therapy and those with recurrent amblyopia. Such prescriptions were for 2 hours per day for around 6 to 8 months. Patients were regularly reviewed every 3 to 4 months to monitor treatment response including VA, refractive errors, compliance, recurrence, and occurrence of occlusion amblyopia.
 
Outcome and statistical analysis
Demographic and baseline characteristics of the 50 patients were collected and analysed. Data relating to BCVA before and after patching, duration and intensity of patching, and compliance (percentage subjectively reported by parents) were collected and analysed.
 
Snellen VA was converted to equivalent logMAR vision for statistical analysis. Treatment success was defined as a BCVA of 20/30 (0.7) or better. Improved VA in both the moderate and severe amblyopia groups were compared with the corresponding ATS 2B and ATS 2A study groups, respectively. All statistical analysis was performed using statistical software (Statistical Package for the Social Sciences; Windows version 16.0; SPSS Inc, Chicago [IL], US). The paired t test, independent t test and Mann-Whitney U test were used as appropriate, and a P value of less than 0.05 was considered significant.
 
Results
The demographic data and treatment results of the 50 patients are shown in Table 1. There were 42 patients with moderate (20/40-20/80) and severe amblyopia (20/100-20/400) as defined by the ATS. The overall success rate (ie final VA >0.7 or 20/30) was 62% (31/50); respective success rates in those with moderate (20/40-20/80) and severe amblyopia (20/100-20/400) were 74% (23/31) and 55% (6/11). The mean VA improvement at 4 months for moderate and severe amblyopia children was 1.0 lines and 6.0 lines, respectively. The mean final VA improvement for the moderately and severely amblyopic children was 2.3 and 5.8 lines, respectively. The respective mean ± standard deviation of moderately and severely amblyopic children for the following outcome measures were: patching prescription, 5 ± 1 (range, 2-7) hours/day and 5 ± 1 (range, 3-6) hours/day; and patching duration, 23 ± 13 (range, 6-57) months and 38 ± 15 (range, 19-66) months. Reported compliance was good (>75% of the time) in 68% (n=34), fair (50-75% of the time) in 22% (n=11), and poor (<50% of the time) in 18% (n=5) of the children. Visual outcomes in relation to patient compliance in patients with moderate and severe amblyopia are shown in Table 2.
 

Table 1. Demographic data and treatment results of children with unilateral amblyopia attending Paediatric Ophthalmology Clinic in United Christian Hospital between January 2009 and March 2009
 

Table 2. Visual outcomes in relation to compliance in patients with moderate and severe amblyopia
 
Subgroup comparisons
There were no significant differences in mean VA improvement between children (i) aged <4 (n=16) and ≥4 (n=34) years; (ii) having good (n=34) and fair-to-poor (n=16) compliance; and (iii) with straight (n=14) and squint (n=36) eyes (Table 3).
 

Table 3. Subgroup patient comparisons according to age, compliance, ocular alignment, and presence of anisometropia*
 
Regarding subgroup comparison for anisometropia (n=12) and non-anisometropia (n=38) groups, the former achieved significantly better mean VA improvements (4.9 vs 2.7 lines, P=0.060). There was no difference in the duration of treatment in the two groups (Table 4).
 

Table 4. Treatment duration and Snellen visual acuity outcomes with reference to the Amblyopia Treatment Study 2 (for children aged 3 to 7 years)*
 
Discussion
Amblyopia is a common condition in paediatric ophthalmology, which is potentially reversible if early treatment is given. It is an important condition warranting efforts to maximise children’s visual potential during their age of visual plasticity. In our locality, the first-line treatment after refractive correction is patching. Although ATS showed similar results with patching as with atropine treatment,10 11 most parents in Hong Kong regard patching more acceptable than atropine, because the latter usually causes visual blurring and may affect the academic performance. This is an important consideration for Hong Kong children who are often busy with schoolwork, including ample near work. Adverse reactions to atropine (flushing and fever) are also common in this locality which also make this form of treatment less popular.
 
Notably, the children in our series received much longer durations of patching treatment than those in ATS (27 vs 4 months), though the final VA improvements were similar (Table 4). In those with severe amblyopia, the mean VA improvement at 4 months was slightly greater than the final improvement. For severe amblyopia, 45% of the children (5/11) were assessed by the Sheridan Gardiner test (suitable for children <4 years old) at 4 months instead of Snellen Acuity charts, though the latter are considered more accurate. All 11 children were using Snellen Acuity charts during the final VA assessment. Maintenance therapy might have extended the treatment duration in certain cases. Assuming Caucasian and Asian eyes as well as environmental visual stimuli were similar, poor compliance could be why longer patching therapy was used to achieve similar VA improvements, even after exclusion of structural abnormalities and correction of refractive errors. In fact, the reported compliance for occlusion therapy has been found to be poor in other studies.12 13 The reported compliance in our case series (68%) was good but suspicious. Due to cultural reason, over-reporting of good compliance was possible in our society. Traditionally, the Chinese regard modest lies more positively than immodest truths.14 Hence, some parents may have overstated the hours of occlusion. A similar situation prevails when we deal with the compliance to anti-glaucomatous eyedrops, in which the reasons for medication non-adherence are complex and may be societal rather than only medical.15 16 Objective measurement of patching compliance and risk factors analysis might be preferable for future studies. Emphasis on compliance to patching is important to communicate when commencing treatment and at every subsequent follow-up visit.
 
Notably, recurrence was much more common in patients with severe amblyopia (46%) than in those in whom it was moderate (7%). This was consistent with the ATS 2C results.6 Tapering of patching to maintain therapy instead of abrupt termination may help to reduce the risk of recurrence.
 
There was a concern about overtreatment, as our dosages were much higher than those in ATS 2B (5 hours/day vs 2 hours/day) for moderate amblyopia. Yet, no occlusion amblyopia was observed in our case series. We believe vigilant and close monitoring of the VA can avoid overtreatment.
 
Since this was a retrospective study, our case series had several limitations, which included small sample size, non-standardised treatment protocol, heterogeneity of case mix, and lack of a control arm. Nonetheless, this study supports the effectiveness of the current Hong Kong practice for amblyopia treatment by patching.
 
Conclusion
Our study showed treatment success rates comparable to those of ATS for moderate amblyopia (74% vs 79% in ATS 2B) and in all children (62% vs 62% in ATS 1). However, larger dosages for moderate amblyopia and longer treatments for both moderate and severe amblyopia appeared necessary for successful treatment in Hong Kong children. Early treatment is important. Maintenance therapy may help to reduce recurrences in children with severe amblyopia. It seems that ATS result cannot be directly applied to Hong Kong children. It is important to emphasise compliance to all parents.
 
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3. Pediatric Eye Disease Investigator Group. A randomized trial of atropine vs patching for treatment of moderate amblyopia in children. Arch Ophthalmol 2002;120:268-78. Crossref
4. Holmes JM, Kraker RT, Beck RW, et al. A randomized trial of prescribed patching regimens for treatment of severe amblyopia in children. Ophthalmology 2003;110:2075-87. Crossref
5. Repka MX, Beck RW, Holmes JM, et al. A randomized trial of patching regimens for treatment of moderate amblyopia in children. Arch Ophthalmol 2003;121:603-11. Crossref
6. Holmes JM, Beck RW, Kraker RT, et al. Risk of amblyopia recurrence after cessation of treatment. J AAPOS 2004;8:420-8. Crossref
7. Newsham D. The effect of recent amblyopia research on current practice in the UK. Br J Ophthalmol 2010;94:1352-7. Crossref
8. Wygnanski-Jaffe T. The effect on pediatric ophthalmologists of the randomized trial of patching regimens for treatment of moderate amblyopia. J AAPOS 2005;9:208-11. Crossref
9. Wygnanski-Jaffe T, Levin AV. The effect of the randomized trial of patching regimens for treatment of moderate amblyopia on pediatric ophthalmologists: 3-year outcome. J AAPOS 2007;11:469-72. Crossref
10. Holmes JM, Beck RW, Kraker RT, et al. Impact of patching and atropine treatment on the child and family in the amblyopia treatment study. Arch Ophthalmol 2003;121:1625-32. Crossref
11. Felius J, Chandler DL, Holmes JM, et al. Evaluating the burden of amblyopia treatment from the parent and child’s perspective. J AAPOS 2010;14:389-95. Crossref
12. Stewart CE, Moseley MJ, Stephens DA, Fielder AR. Treatment dose-response in amblyopia therapy: the monitored occlusion treatment of amblyopia study (MOTAS). Invest Ophthalmol Vis Sci 2004;45:3048-54. Crossref
13. Newsham D. Parental non-concordance with occlusion therapy. Br J Ophthalmol 2000;84:957-62. Crossref
14. Fu G, Brunet MK, Lv Y, et al. Chinese children’s moral evaluation of lies and truths—roles of context and parental individualism-collectivism tendencies. Infant Child Dev 2010;19:498-515.
15. Friedman DS, Okeke CO, Jampel HD, et al. Risk factors for poor adherence to eyedrops in electronically monitored patients with glaucoma. Ophthalmology 2009;116:1097-105. Crossref
16. Wu HY, Yin JF. Clinical investigation of medication adherence of glaucoma patients [in Chinese]. Zhonghua Yan Ke Za Zhi 2010;46:494-8.

Intensive care unit admission of obstetric cases: a single centre experience with contemporary update

Hong Kong Med J 2014;20:24–31 | Number 1, February 2014 | Epub 20 Jun 2013
DOI: 10.12809/hkmj133924
© Hong Kong Academy of Medicine. CC BY-NC-ND 4.0
 
ORIGINAL ARTICLE
Intensive care unit admission of obstetric cases: a single centre experience with contemporary update
Vivian KS Ng, MB, ChB, MRCOG1; TK Lo, MB, BS, FHKAM (Obstetrics and Gynaecology)1; HH Tsang, MRCP, FHKAM (Medicine)2; WL Lau, MB, BS, FHKAM (Obstetrics and Gynaecology)1; WC Leung, MD, FHKAM (Obstetrics and Gynaecology)1
1 Department of Obstetrics and Gynaecology, Kwong Wah Hospital, Yaumatei, Kowloon, Hong Kong
2 Department of Intensive Care, Kwong Wah Hospital, Yaumatei, Kowloon, Hong Kong
 
Corresponding author: Dr VKS Ng (vivian_nks@hotmail.com)
Abstract
Objectives: To review the characteristics of a series of obstetric patients admitted to the intensive care unit in a regional hospital in 2006-2010, to compare them with those of a similar series reported from the same hospital in 1989-1995 and a series reported from another regional hospital in 1998-2007.
 
Design: Retrospective case series.
 
Setting: A regional hospital in Hong Kong.
 
Patients: Obstetric patients admitted to the Intensive Care Unit of Kwong Wah Hospital from 1 January 2006 to 31 December 2010.
 
Results: From 2006 to 2010, there were 67 such patients admitted to the intensive care unit (0.23% of total maternities and 2.34% of total intensive care unit admission), which was a higher incidence than reported in two other local studies. As in the latter studies, the majority were admitted postpartum (n=65, 97%), with postpartum haemorrhage (n=39, 58%) being the commonest cause followed by pre-eclampsia/eclampsia (n=17, 25%). In the current study, significantly more patients had had elective caesarean sections for placenta praevia but fewer had had a hysterectomy. The duration of intensive care unit stay was shorter (mean, 1.8 days) with fewer invasive procedures performed than in the two previous studies, but maternal and neonatal mortality was similar (3% and 6%, respectively).
 
Conclusion: Postpartum haemorrhage and pregnancy-induced hypertension were still the most common reasons for intensive care unit admission. There was an increasing trend of intensive care unit admissions following elective caesarean section for placenta praevia and for early aggressive intervention of pre-eclampsia. Maternal mortality remained low but had not decreased. The intensive care unit admission rate by itself might not be a helpful indicator of obstetric performance.
 
 
New knowledge added by this study
  • There was an increasing trend of obstetric intensive care unit (ICU) admissions but with shorter stays.
  • Well-planned fertility-sparing treatments for postpartum haemorrhage and placenta praevia may decrease resorting to hysterectomy.
Implications for clinical practice or policy
  • Other performance indicators in addition to crude ICU admission rates should be established to evaluate obstetric standards.
 
Introduction
Obstetric admissions to the intensive care unit (ICU) and maternal mortality continue to have a significant impact on maternal health care, despite the low rate of such admissions in developed countries.1 Unlike others, obstetric patients pose a major management challenge to ICU physicians and obstetricians due to altered physiology during pregnancy, consideration of fetal wellbeing, and the unique type of disorders to be dealt with.
 
Despite ongoing improvements in obstetric care, more patients were admitted to ICU in the reviewed period compared with decades earlier.2 Thus, the purpose of this study was to review and compare the characteristics of obstetric patients admitted to the ICU over the recent 20 years using historical controls, with respect to their epidemiology, medical background, antenatal and peripartum risks, durations of ICU stay, interventions in the ICU, and predictability of the Acute Physiology and Chronic Health Evaluation (APACHE II) score, as well as maternal and fetal outcomes.
 
Methods
This was a retrospective case series of obstetric patients admitted to the ICU of Kwong Wah Hospital, Hong Kong, over a 5-year period from 1 January 2006 to 31 December 2010. Our hospital provides joint care with seven other hospitals in the Kowloon West Cluster to residents of six districts, which account for about 1.9 million inhabitants. Our obstetric service is available for 24 hours each day for women in parts of the Kowloon West and Wong Tai Sin districts. We provide out-patient and in-patient services, including antenatal check-ups, prenatal diagnoses, elective and emergency operations and services that are supported by a blood bank and various laboratory test facilities available for patients in hospital and in the community. Moreover, 24-hour midwifery, and perinatal and anaesthetic services are available in our delivery suite. Our team consists of consultants, associate consultants, as well as senior and junior residents. Three staff (one specialist, two residents) are always available on site for emergency admissions. Annually, we manage 5000 to 6000 deliveries, which is one of the highest delivery rates for a Hong Kong hospital. Our ICU was established in 1968, currently has 14 beds, and admits 500 to 600 patients every year. The ICU team consists of a critical care physician, a resident anaesthetist, medical and surgical residents, and a nursing team with critical care–registered nurse specialists.
 
This study was approved by the Ethics Committee of the Kowloon West Cluster, Hospital Authority. No patient consent was required as the study only involved review of medical records.
 
Obstetric patients from 24 weeks of gestation onwards to 6 weeks postpartum admitted to the ICU were reviewed. They were identified via the computerised database system adopted by the ICU. All corresponding medical records were reviewed in detail. Supplementary information was retrieved from the Clinical Management System, Electronic Patient Record, and Obstetrics Clinical Information System.
 
Data retrieved for analysis included patient demographics (age, ethnicity, smoking and drinking status, parity, order of pregnancy, and body mass index [BMI] at booking visit), antenatal booking status, number of antenatal visits, medical history, perinatal risks, gestation at and mode of delivery, indications for caesarean section, interventions involved at and after delivery, indications and admission status to the ICU, and maternal and fetal outcomes. Patient mortality was predicted by recourse to the APACHE II score.
 
Indications for ICU admission were divided into obstetric and non-obstetric causes. Obstetric causes were those unique to pregnancy or liable to occur within 6 weeks of delivery. Non-obstetric causes were those not specifically related in pregnancy.
 
Interventions provided by ICU physicians were classified into non-invasive and invasive. Those deemed non-invasive included insertion of arterial or central lines, blood product transfusion, use of continuous positive airway pressure (CPAP) ventilation, and use of inotropes. Invasive procedures included invasive mechanical ventilation, cardiopulmonary resuscitation (CPR), defibrillation, and haemodialysis.
 
Immediate and long-term complications of the mothers and neonates were assessed up to 6 to 8 weeks post-delivery. Maternal and perinatal mortalities were also calculated.
 
Data were entered manually into Excel and analysed using the Statistical Package for the Social Sciences (SPSS version 17, Chicago [IL], US). The data were compared with those from the results of a historical review in the same hospital (1989-1995, by Tang et al2) and a review in another regional hospital (1998-2007, by Leung et al3). Chi squared or Fisher’s exact tests were used to compare proportions and Student’s t test to compare continuous variables.
 
Results
In all, 67 relevant patients were admitted to the ICU and reviewed during the period of 1 January 2006 to 31 December 2010, which amounted to 0.23% of the total hospital maternities and 2.34% of all ICU admissions (Table 1). Their demographic features are shown in Table 2. The mean age of women at delivery was 34 (standard deviation [SD], 5; range, 20-42) years. Thirty (45%) of the patients were of advanced maternal age (ie age at confinement of ≥35 years). The majority of them were Chinese (n=65, 97%), one was Filipino and one an Indonesian. Nine (13%) patients were visitors from mainland China. Seven (10%) were smokers, two (3%) drank alcohol regularly and two (3%) had a history of substance abuse. In all, 38 (57%) were nulliparous and six (9%) carried twin pregnancies. Most of the patients (n=61, 91%) were booked in our unit; 19 (28%) had three antenatal check-ups or less.
 

Table 1. Intensive care unit (ICU) admission of obstetric patients
 

Table 2. Basic demographics
 
Among these 67 patients, 39 (58%) enjoyed good past health, and six (9%) had a BMI of more than 25 kg/m2 at their booking visit. The most common co-existing diseases were gynaecological (n=11, 16%) and haematological (n=9, 13%). Their antenatal and peripartum risks are summarised in Table 3.
 

Table 3. Past health, antenatal and peripartum risks (more than one entry possible)
 
The mean gestational age at delivery was 37 (SD, 6; range, 27-41) weeks. Most of them were delivered by emergency caesarean section (n=34, 51%), including one transferred to us after delivery in the private sector. One patient remained undelivered and died antenatally. Placenta praevia and pregnancy-induced hypertensive disorders were the main indications for elective and emergency caesarean sections, respectively. Other indications are listed in Table 4.
 

Table 4. Mode of delivery
 
The reasons for ICU admission and procedures undertaken therein are listed in Table 5. Most were admitted to the ICU postpartum (n=65, 97%) and for obstetric problems (n=58, 87%), of which postpartum haemorrhage (PPH) was the leading cause (n=39, 58%) followed by pre-eclamptic toxaemia (PET) or eclampsia (n=17, 25%). The mean duration of ICU stay was 1.8 (SD, 1.2; range, 0.5-10) days; four (6%) of the patients stayed for more than 3 days.
 

Table 5. Reasons for intensive care unit (ICU) admission
 
In all, 39 patients were admitted to the ICU due to a PPH, the mean estimated blood loss was 4852 mL. Major causes of PPH were related to placenta praevia (n=16), uterine atony (n=12), and perineal trauma (n=5). Blood products given included packed cells (mean, 12 units), platelet concentrate (mean, 5 units), fresh frozen plasma (mean, 7 units), and cryoprecipitate (mean, 1 unit). Three patients received recombinant factor VIIa (NovoSeven; Novo Nordisk A/S, Bagsværd, Denmark). Procedures to control PPH included compression sutures (n=10), uterine artery embolisation (n=9), insertion of a Sengstaken-Blakemore tube (n=6), and uterine artery ligation (n=2). There were 13 patients who underwent hysterectomy despite multiple other interventions and use of multiple uterotonics, and eight patients with PPH were complicated with disseminated intravascular coagulation, one had a ventricular tachycardia, and one had a urinary tract injury. One of the patients with a PPH and anaphylactic shock suffered a cavernous sinus thrombosis and a cranial nerve VI palsy, for which she received therapeutic doses of low-molecular-weight heparin. Another patient was admitted 2 weeks after delivery due to delirium secondary to sepsis.
 
There were 17 patients admitted to the ICU for PET or eclampsia (9 of whom had eclampsia) and were all stabilised in the ICU. Two patients had HELLP (haemolysis, elevated liver enzymes, low platelets) syndrome and two had hypertensive encephalopathy diagnosed on the basis of computed tomography. Other complications included acute pulmonary oedema (n=1), deranged renal function (n=3), deranged liver function (n=1), and aspiration pneumonitis (n=1). Another eight had persistent hypertension 6 weeks postpartum and were referred to physicians.
 
Regarding the 10 patients (15% of the cohort) admitted to the ICU for non-obstetric reasons, two had an epileptic seizure, three had cardiovascular problems (cardiomyopathy, heart failure, and pulmonary hypertension), and one each had renal disease, ethanol toxicity, acute pulmonary oedema, myasthenia gravis, and anaphylactic shock.
 
Invasive procedures performed in the ICU were CPR (n=2, 3%) and mechanical ventilation (n=7, 10%). Non-invasive procedures were blood product transfusions (n=36, 54%), central line insertion (n=18, 27%), arterial line insertion (n=24, 36%), use of inotropes (n=2, 3%), and CPAP ventilation (n=1, 2%).
 
The mean APACHE II score was 17 (range, 4-37) and the mean predicted mortality rate was 28% (range, 4-85%). The actual mortality rate in this series was 3% (Table 6). The maternal mortality ratio (MMR; actual/predicted mortality) was 0.11.
 

Table 6. Morbidity and mortality
 
In our study period, there were two maternal deaths in the 28 976 maternities or 7 per 100 000 births, both in ICU patients. One was a patient who enjoyed good health but suspected to have pulmonary hypertension at 27 weeks of gestation, who rapidly deteriorated and died 1 day after admission. Her diagnosis was confirmed at postmortem examination. The other maternal death ensued in the postpartum period due to multi-organ failure and brain death, secondary to eclampsia and intraventricular haemorrhage.
 
Regarding these ICU admissions, three (5%) of the fetuses endured intrauterine death (IUD) and one (2%) whose neonate died (due to necrotising enterocolitis). The IUDs were associated with abruptio placentae, pulmonary hypertension, and severe pre-eclampsia with early intrauterine growth restriction.
 
Discussion
The health care system of Hong Kong aims to protect/ improve maternal and child health, by means of antenatal, intrapartum, and postnatal services that are readily available at very low costs. Whilst the MMR fluctuated between 1.0 and 11.2 per 100 000 live births over the past 31 years,4 5 the above-mentioned services have contributed to the decreasing and now very low maternal mortality rates.
 
Despite advances in obstetric care, the admission rate to the ICU had doubled compared with a decade ago (from 0.12% to 0.23%).2 Whereas such ICU utilisation rates for obstetric cases were also higher compared with Tang et al’s data2 (2.34% vs 0.61%), nevertheless they were low compared to reports from overseas.6 7 The rates were also higher than those reported by Leung et al (admission, 0.13%; utilisation, 0.65%).3 One of the reasons for the rise in ICU admission rates was changes in patient allocation in our hospital, and over the Hong Kong Special Administrative Region. The number of beds in our ICU was reduced from 18 to 14 after the severe acute respiratory syndrome epidemic in 2003. The number of surgical admissions was also much lower than a decade earlier. Moreover, the number of trauma cases dropped significantly, since two other nearby tertiary hospitals became trauma centres. Changing attitudes of obstetricians and anaesthetists also contributed to the increase in ICU admission rate. Given the fact that our patients were most commonly delivered by elective caesarean section for placenta praevia, a proper preoperative management plan with a multidisciplinary approach involving anaesthetist, intensive care physician, and obstetricians should have been available before the operation, which included booking of the ICU bed. With the increasing trend of placenta praevia, it was expected that more and more patients would be admitted to the ICU electively for monitoring rather than any future active intervention. The shorter duration of ICU stays, compared with those detailed earlier by Tang et al,2 is probably consistent with this trend towards elective admissions.
 
The mean age of our patients at delivery was higher than that in the patient series described by Tang et al2 and Leung et al.3 Indeed, patients of advanced maternal age were more likely to be admitted to the ICU when compared with our background population, though this was not shown for such ICU admissions reported by Selo-Ojeme et al.8 Increasing maternal age implies that our patients were more likely to have co-existing diseases complicating pregnancy, as reflected by our data, even though the medical problems in question were generally mild and stable.
 
According to Tang et al’s2 and Leung et al’s3 reports about non-booked cases (NBCs), patients from mainland China used to be admitted via the emergency department very late when they went into advanced labour. As a result, potential or present obstetric complications were known to us only when they were admitted. With the commencement of the policy to allow these mothers to register and deliver in Hong Kong (since 2007), the number of NBCs decreased significantly, as did their number of ICU admissions.
 
In the literature there are conflicting data when parity is considered one of the risk factors for ICU admission. In our study, nulliparity was not related to ICU admission, which was also what Pollock et al noted.6
 
During our data analysis, twin pregnancy was more likely in our ICU patients compared with the background population. However, such data cannot be retrieved from Tang et al’s or Leung et al’s reports.2 3 Twin pregnancy is known to confer a higher risk of gestational diabetes, hypertension, premature delivery, operative deliveries, and postpartum complications (including PPH).9 10 Our findings also supported the need of a specialised twin pregnancy clinic to look after this high-risk group.
 
Placenta praevia was the most frequent risk factor identified in our patient series, being much more common than in Tang et al’s study.2 Increasing popularity of evaluation by ultrasound has raised the detection rate of placenta praevia early in the antenatal period. All our patients with placenta praevia were delivered electively with proper preoperative arrangements. These entailed booking of ICU facilities, standby uterine artery embolisation, preparation of recombinant factor VIIa and Sengstaken-Blakemore tubes, and involvement of obstetric consultants to make decisions. One consequence was a significantly higher number of elective caesarean sections for placenta praevia compared with decades ago, though the overall section rate remained relatively stable.11 This also correlated with placenta praevia being the commonest causes of PPH in our ICU patients.
 
As in Tang et al’s2 and Leung and et al’s3 studies, in our series admissions due to obstetric problems remained the main cause of obstetric ICU admissions. Postpartum haemorrhage was consistently the most common indication for ICU admission, which was also noted in Tang et al’s series.2 Although the mean estimated blood loss of our patients was apparently higher than that reported by Tang et al,2 and abdominal delivery is known to increase the risk of hysterectomy following PPH,12 the number of hysterectomies performed was significantly lower than before. The increasing use of compression sutures and uterine artery embolisation together with strategies to retain the placenta in cases of placenta accreta might account for the decreasing recourse to hysterectomy compared with 20 years ago.
 
The current series had more patients with pre-eclampsia or eclampsia admitted to the ICU than those reported by Tang et al,2 although the difference was not statistically significant. As suggested by the National Institute for Health and Clinical Excellence guideline,12 our management protocol was updated to incorporate the more liberal use of antihypertensives and magnesium sulphate. Our use of the modified early obstetric warning scoring system allowed early detection of potential complications to prevent poor obstetric outcomes. Intensive care is indicated in patients with severe hypertension, or moderate hypertension with symptoms of impending eclampsia or any suggestion of organ dysfunction. These innovations lead to the rising trend of ICU admissions to monitor for pre-eclampsia.
 
Active involvement of anaesthetists plays a role in the changing pattern of obstetric ICU admissions. There was a drastic reduction of admissions for anaesthesia-related causes compared with those reported by Tang et al.2 Only one of our patients was admitted due to anaphylactic shock, which can be explained by the significant improvements in anaesthetic care and mechanical ventilation in our hospital. Invasive and non-invasive procedures (eg intubation and insertion of arterial and central venous lines) undertaken in the ICU were significantly fewer than decades ago, as most of them had been performed before admission to ICU by anaesthetists.
 
In our series, the mean duration of ICU stay was 1.8 days, which was shorter than 4.1 days reported in Tang et al’s study.2 The change in attitude and approach to management of both obstetricians and anaesthetists made ICU admission a more elective occurrence than before. As a result, patients admitted to the ICU tended to be more stable and fewer invasive interventions were warranted. These observations highlight the need for obstetric high-dependency units to cater for patients requiring more intensive care, but not to the extent of ICU support.13
 
When compared with the findings reported by Leung et al,3 over the decades there was no significant increase in perinatal mortality, nor was there an increased rate of fetal loss when compared with our background population. Nevertheless, maternal mortality had not decreased. In our series, there were two maternal deaths that amounted to a mortality rate of 7 per 100 000 maternities. In Tang et al’s series2 the maternal mortality was 5 per 100 000, and in the UK it was reported to be 14 and 11 per 100 000 in 2003-2005 and 2006-2008, respectively.14 However, these differences between series were not statistically significant.
 
One limitation of our study was that data collection from the computerised system might have omitted pregnant women admitted to the ICU from other specialties with diagnoses that were not obstetrically related. A second limitation was that the causes of maternal ICU admission may not relate directly to the causes of maternal mortality. For example, thromboembolism, one of the leading causes of maternal death in the UK, was not a major cause of ICU admission. In the UK, only 30% of such maternal deaths were in patients admitted to the ICU,15 and on this issue there is no global consensus on the optimal indications for ICU admission. A third limitation was that the frequency of obstetric ICU admissions is also affected by the standard of obstetric care and the threshold admission criteria determined by obstetricians, anaesthetists, and intensive care physicians. As a result, ICU admissions may not truly reflect the standard of obstetric care.16 A composite performance indicator of obstetric care by combining the frequency of ICU admission, numbers of emergency admissions and/or proportions of emergency/elective admissions, and proportions having prolonged stays (eg >3 days) could be a more useful measure of the standard of obstetric practice in the future.
 
The APACHE II scoring system has been used as a quantitative predictor of mortality, mainly in medical and surgical patients admitted to the ICU using several physiological measures. Its potential has also been evaluated when applied to obstetric patients. According to different overseas reviews, it may overestimate risks in pregnant patients, as in them normal physiology can differ, often in subtle ways, and can undergo abrupt changes in various emergency conditions.17 18 Thus, to date, there is still no proper screening system for obstetric emergencies. A specific scoring system for obstetric patients should be developed and warrants a large-scale international prospective study for this purpose.
 
The majority of patients discharged from our ICU enjoyed satisfactory recoveries in the puerperal period. In all, eight patients with hypertensive disorder in pregnancy had persistent hypertension for which they were referred for medical assessment. In our series, long-term outcome was not determined. Leung et al3 found that women admitted to the ICU had lower mean scores for quality of life than normal Hong Kong females of similar age, but these authors commented that the relationship of low scores to the obstetric illnesses was unclear and might be resolved by long-term patient follow-up.
 
In some respects, Leung et al’s study3 also provided us with geographical controls. However, they included patients with gestational ages of <24 weeks, which complicated any comparison of risk factors. Moreover, being intensive care physicians they emphasised quality of life after discharge from the ICU. In contrast, we obstetricians looked for indicators to prevent/reduce maternal ICU admissions, as advocated in modern obstetrical care guidelines.
 
Conclusion
Our findings illustrate the various changes in ICU admission practice of obstetric cases in the last 20 years, and are comparable to those in other developed countries. Elective caesarean section for placenta praevia and PPH were the major reasons for ICU admission. More conservative management of placenta praevia and PPH appeared to reduce resorting to hysterectomy. These ongoing changes in practice may make emergency obstetric admissions to the ICU less likely in the future. Maternal mortality in our unit has remained low over the years, and can hardly be reduced any further. It is therefore more important to refine and improve obstetric practice to reduce maternal morbidity. The ‘near-miss’ in terms of obstetric ICU admission rates, together with measures targeting the duration of ICU stay, and a potential obstetric morbidity scoring system will no doubt better reflect our clinical performance standards in the future.
 
References
1. Public Health Agency of Canada. Make every mother and child count: report on maternal and child health in Canada. 2005. Available from: http://publications.gc.ca/collections/ Collection/H124-13-2005E.pdf. Accessed Jun 2010.
2. Tang LC, Kwok AC, Wong AY, Lee YY, Sun KO, So AP. Critical care in obstetrical patients: an eight-year review. Chin Med J (Engl) 1997;110:936-41.
3. Leung NY, Lau AC, Chan KK, Yan WW. Clinical characteristics and outcomes of obstetric patients admitted to the intensive care unit: a 10-year retrospective review. Hong Kong Med J 2010;16:18-25.
4. Department of Health, Hong Kong. Chapter 1: Health of community. Annual Report 2009/2010.
5. Department of Health, Hong Kong. Number of maternal deaths by major disease group, 2001-2009. Available from: www.healthyhk.gov.hk/phisweb/reports/2009_01_01_ MOT00101.xls. Accessed Aug 2010.
6. Pollock W, Rose L, Dennis CL. Pregnant and postpartum admissions to the intensive care unit: a systematic review. Intensive Care Med 2010;36:1465-74. Crossref
7. Togal T, Yucel N, Gedik E, Gulhas N, Toprak HI, Ersoy MO. Obstetric admissions to the intensive care unit in a tertiary referral hospital. J Crit Care 2010;25:628-33. Crossref
8. Selo-Ojeme DO, Omosaiye M, Parijat Battacharjee P, Kadir RA. Risk factors for obstetric admissions to the intensive care unit in a tertiary hospital: a case-control study. Arch Gynecol Obstet 2005;272:207-10. Crossref
9. Liu AL, Yung WK, Yeung HN, et al. Factors influencing the mode of delivery and associated pregnancy outcomes for twins: a retrospective cohort study in a public hospital. Hong Kong Med J 2012;18:99-107.
10. Yung WK, Liu AL, Lai SF, et al. A specialised twin pregnancy clinic in a public hospital. Hong Kong J Gynaecol Obstet Midwifery 2012;12:21-32.
11. Department of Obstetrics and Gynaecology, Kwong Wah Hospital. Annual Report 2006-2010.
12. National Institute for Health and Clinical Excellence. Caesarean section. NICE Clinical Guidelines, No 132. 2010.
13. Mirghani HM, Hamed M, Ezimokhai M, Weerasinghe DS. Pregnancy-related admissions to the intensive care unit. Int J Obstet Anesth 2004;13:82-5.  Crossref
14. Cantwell R, Clutton-Brock T, Cooper G, et al. Saving mothers’ lives: reviewing maternal deaths to make motherhood safer: 2006-2008. The eighth report on confidential enquiries into maternal deaths in the United Kingdom. BJOG 2011;118(Suppl 1):1S-203S. Crossref
15. Lewis G, Clutton-Brock T, Cooper G, et al. Saving mothers’ lives: reviewing maternal deaths to make motherhood safer–2003-2005. The seventh report on confidential enquiries into maternal deaths in the United Kingdom. London: CEMACH; 2007.
16. Baskett T, Sternadel J. Maternal intensive care and near-miss mortality in obstetrics. Br J Obstet Gynaecol 1998;105:981-4.  Crossref
17. Vasquez DN, Estenssoro E, Canales HS, et al. Clinical characteristics and outcomes of obstetric patients requiring ICU admission. CHEST 2007;131:718-24.  Crossref
18. Gilbert TT, Smulian JC, Martin AA, et al. Obstetric admissions to the intensive care unit: outcomes and severity of illness. Obstet Gynecol 2003;102:897-903.  Crossref

Physiotherapist-designed aquatic exercise programme for community-dwelling elders with osteoarthritis of the knee: a Hong Kong pilot study

Hong Kong Med J 2014;20:16–23 | Number 1, February 2014 | Epub 11 Sep 2013
DOI: 10.12809/hkmj133931
© Hong Kong Academy of Medicine. CC BY-NC-ND 4.0
 
ORIGINAL ARTICLE
Physiotherapist-designed aquatic exercise programme for community-dwelling elders with osteoarthritis of the knee: a Hong Kong pilot study
Mary CK Lau, MHM, Prof Dip Phty; Joseph KS Lam, Prof Dip Phty; Eva Siu, MPH, Prof Dip Phty; Carmen SW Fung, MScHC(PT), Prof Dip Phty; Kevin TY Li, MHE&HP, Prof Dip Phty; Margaret WF Lam, Prof Dip Phty
Shatin VHT Office, Elderly Health Service, Department of Health, Room 326, Shatin Government Offices, 1 Sheung Wo Che Road, Shatin, Hong Kong
 
Corresponding author: Dr MCK Lau (mary_lau@dh.gov.hk)
Abstract
Objectives: To examine the effectiveness and feasibility of a community-based aquatic exercise programme for elders with osteoarthritis of the knee.
 
Design: Prospective intervention study, with a before-and-after design.
 
Setting: Community elders.
 
Participants: Twenty elders aged 65 years or above (mean, 72 years) attending four Elderly Health Centres of the Department of Health who had suffered from osteoarthritis of the knee for at least 3 years and with mild-to-severe knee pain.
 
Intervention: A 10-week aquatic exercise programme designed and led by physiotherapists.
 
Main outcome measures: Range of motion and power of extension of the knees, functional reach test, repeated sit-to-stand test, and the Chinese Arthritis Impact Measurement Scales 2.
 
Results: There was an improvement in the median range of knee flexion from 115° to 125° (P<0.01) and the median strength of the quadriceps from 9 kg to 21 kg (P<0.001). The median score of the functional reach test increased from 20 cm to 28 cm (P<0.001) and the repeated sit-to-stand test from 10 to 14 repetitions (P<0.001). Also, there was an improvement in the mobility level (P<0.01), walking and bending ability of the trunk (P<0.05), levels of pain (P<0.01) and mood (P<0.01), and the total score (P<0.01) in the Chinese Arthritis Impact Measurement Scales 2.
 
Conclusions: Physiotherapist-designed aquatic exercise has definite benefits in terms of physical and psychosocial functioning, and should be promoted as one of the strategies to enhance long-term self-management of community elders with knee osteoarthritis.
 
 
New knowledge added by this study
  • This physiotherapist-designed aquatic exercise (PDAE) programme significantly improves knee functions, symptoms, and psycho-social functioning of the Hong Kong Chinese knee osteoarthritis (OA) sufferers.
  • The PDAE programme was effective and feasible in community settings.
Implications for clinical practice or policy
  • This study showed that OA knee sufferers can improve in terms of knee symptoms and functioning by means of the PDAE programme used in a community setting.
  • The findings support the application of PDAE programme as a form of long-term self-management for OA knee.
 
Introduction
Osteoarthritis of the knee (OA knee) is a chronic painful and disabling condition affecting elderly persons worldwide. Among all lower limb joints affected by OA, affliction of the knee is particularly common among the Hong Kong Chinese. A local survey on persons aged 50 years and above revealed that among men, 17% and 7% had persistent knee pain and a confirmed diagnosis of OA knee, respectively; the prevalence rates in women were higher, being 24% and 13%, respectively.1
 
Elderly Health Centres (EHCs) of the Department of Health provide comprehensive primary health care for persons aged 65 years and above. Among attendees of EHCs, OA knee contributes to approximately one third of all physiotherapy referrals.2
 
Physiotherapy in the form of an exercise prescription (eg hydrotherapy), other treatment modalities (eg heat therapy, transcutaneous electrical nerve stimulation), as well as the prescription of mobility aids for improving ambulation are examples of recommended non-pharmacological therapies for the OA. These are in addition to patient education and self-management programmes.3 There are many studies documenting the efficacy and effectiveness of aquatic exercises (or hydrotherapy programmes) for reducing pain and improving function in patients with OA or rheumatoid arthritis.4 5 6 7 8 When one exercises in water, the buoyancy of water decreases loading on lower limb joints. On the other hand, the hydrodynamic resistance and turbulence helps to strengthen muscles and increase proprioception and balance. Hydrostatic pressure also helps to control oedema in the immersed body parts.
 
This study aimed to examine the effectiveness and feasibility of a community-based aquatic exercise programme for elders with OA knee. The programme, a physiotherapist-designed aquatic exercise (PDAE), was developed by the physiotherapists of the Elderly Health Service (EHS) of the Department of Health.
 
Methods
Subjects
Subjects were recruited by convenience sampling of the elders aged 65 years and above attending any one of the four EHCs in Kowloon, Hong Kong.
 
Inclusion and exclusion criteria
Elders who were recruited had to have a clinical diagnosis of OA knee made by EHC doctors, knee pain for at least 3 years, and a self-perceived pain level of at least ‘mild’ in the affected knee joint(s) during the preceding 1 month.
 
Unstable heart disease, hypertension, or any other medical contra-indication to mild-to-moderate physical activity were grounds for exclusion. Other exclusion criteria were physical barriers to exercising in water, such as marked postural deformity, blindness, or deafness; severe cognitive impairment; depression not responding to treatment; neurological diseases like Parkinson’s disease and stroke; and inability to walk independently. Subjects who had already received active interventions for OA knee during the preceding 2 months or who had scheduled knee operations in the following 6 months were also excluded.
 
Interventions
The PDAE consisted of individual and group exercises (Table 1), and was delivered twice a week for 10 weeks in a public indoor swimming pool by registered physiotherapists of the EHS.
 

Table 1. Details of the physiotherapist-designed aquatic exercise (PDAE) programme
 
All subjects attended a health educational seminar on OA knee and the PDAE before the programme. This addressed the aetiology of OA knee, advice on joint care, skills about coping with daily living and self-help tips on symptomatic relief, a rundown of the programme, and the preparation required before undertaking the aquatic exercises.
 
Measurements
Characteristics of subjects
Measurements were carried out in the week preceding and then following the intervention. Demographic and co-morbidity data, including the body mass index (BMI), were collected at baseline. The history of knee pain and its management, self-reported levels of involvement in household work and exercise habits, and details about each subject’s living environment were also documented.
 
Outcome measures
The outcome measures were:
(1) Self-reported changes in the use of analgesics (type and frequency of use).
(2) Changes in functional status, intensity and pattern of pain, social activity, and level of tension and mood, as measured by the Chinese Arthritis Impact Measurement Scales 2 (CAIMS 2). The CAIMS 2 has been validated on Chinese-speaking patients with arthritis9 (Table 2). Thirty relevant items were extracted using CAIMS 2 in the current study, and dealt with mobility, lower limb functions, arthritis pain, and psychosocial status.
(3) Functional exercise capacity was measured by the 6-minute walk test, which measures the maximum distance walked along a 50-metre indoor course in 6 minutes.10 Learning effects were minimised by testing each subject once in the pre- and post-test, respectively and by a 3-month period between the tests.
(4) Lower limb strength and function were measured using the dynamometer test of the Nicholas Manual Muscle Tester (NMMT) and the 30-second repeated sit-to-stand test. The NMMT measures isometric quadriceps muscle strength at 30° of knee flexion. The 30-second repeated sit-to-stand test entails counting the number of completed repetitions by the subject in 30 seconds, and reflects composite functional strength contributed by extension of the back and legs.
(5) Standing balance was measured by the functional reach test (FRT), which measures the maximum displacement in horizontal distance that the subjects can reach when they stand still. Scores of less than 6 inches (15.2 cm) indicate limited functional balance, 6 to 10 inches indicate a moderate fall risk, and that of more than 10 inches (25.4 cm) indicate less fall risk.11
(6) The range of motion (ROM) of the knee joints was measured by a goniometer with the subject in a lying position. The range is one of the mediators for the improvement in overall knee function.
 

Table 2. The selected items for physiotherapist-designed aquatic exercise assessment out of the original Chinese Arthritis Impact Measurement Scales 2 (CAIMS 2) questionnaire9
 
Programme feasibility
The feasibility of running the PDAE programme in the community was assessed as follows:
(a) Difficulties encountered and subjects’ concerns during the recruitment;
(b) Attendance during programme implementation and reasons of absence;
(c) Observation of subjects’ performance during the PDAE programme; and
(d) Post-study programme evaluation including subjects’ satisfaction and their opinion on future service planning.
 
Statistical methods
Analyses were performed using the Statistical Package for the Social Sciences (Windows version 10.0; SPSS Inc, Chicago [IL], US). Differences in range of knee movement, quadriceps strength, FRT, repeated sit-to-stand test, 6-minute walk test, and CAIMS 2 scores before and after the PDAE were tested by the Wilcoxon signed rank test, while the difference in the use of analgesic medications for knee pain was tested by McNemar’s test.
 
To detect a change of 20% in the pain and physical functioning scales of CAIMS 2 with an α level of 0.05 and 80% power, a sample size of 18 was necessary according to the computer equation for the Wilcoxon signed rank test. To allow for a dropout rate of 20%, 22 subjects were recruited.
 
Results
Subject characteristics
There were 22 subjects, of whom 20 (15 female and 5 male) completed the PDAE programme. Two withdrew from the study—one due to personal and adjustment problems to water temperature, while the other did not attend the post-programme assessment. The mean (± standard deviation) age of the subjects was 72 ± 2 years. In all, 35% of them were illiterate and 50% had had a primary school education (Table 3). Apart from OA of the knee, 65% of them had other musculoskeletal problems. Moreover, 65% of the subjects lived in public housing and the rest in private housing. All of them were involved in managing household chores at moderate (60%) and light (40%) intensity levels, and 90% of them had direct lift access to their homes.
 

Table 3. Demographic and clinical characteristics of the sample*
 
Before participating in PDAE programme, 16 of the subjects had pain in both knees and four in one knee only. Specific causes of the knee pain were not identified in 15 of them. Two subjects had pain in one knee without specific cause but the other knee by trauma. Two subjects had knee pain due to overuse. Another subject had knee pain due to overuse and trauma. The main aggravating factors were climbing stairs, squatting, weather changes, and getting up from a sitting to standing position (Table 3).
 
Nearly all the subjects (90%) undertook exercises of different forms and intensity; 94% claimed to exercise daily, 78% claimed to exercise 30 to 60 minutes per day, and some (17%) claimed to exercise for more than 1 hour a day. Reported land-based exercises included walking (60%), general mobilisation exercise (55%), and Tai Chi (40%). Half of the subjects encountered difficulties performing daily activities (brisk walking, single-leg standing, squatting, getting up or standing from squatting, or sitting on a low stool) due to knee problems. Subject demographics and clinical features are described in Table 3.
 
Body mass index
There was no significant difference in the subjects’ mean BMI before and after the PDAE programme (26.6 vs 26.6 kg/m2; P=0.658).
 
Pain-relieving medications
Before PDAE, more than half of the subjects used analgesic ointments/patches for self-management of knee pain. Apart from medication, only one subject exercised specifically to relieve pain and stiffness in his knee. Three quarters of the subjects found their self-management slightly effective and 20% found it moderately effective.
 
After PDAE, the number of subjects taking pain-relieving medications decreased (19 vs 4; P=0.004), and the numbers relying on oral analgesics decreased from four to one (Table 4).
 

Table 4. Frequency and type of analgesic medication used before and after physiotherapist-designed aquatic exercise (PDAE) programme
 
Outcomes
According to observations by physiotherapists, subjects with knee swelling all experienced a decrease (10 vs 0 knees; P=0.002). There was also a decrease in the girth of the thigh (measured at 5 cm above the base of patella in both knees) from a mean of 40 cm to 39 cm (P<0.001), despite a substantial increase of muscle strength (Tables 5 and 6).
 

Table 5. Functional parameters of the knee before and after physiotherapist-designed aquatic exercise (PDAE) programme
 

Table 6. The Chinese Arthritis Impact Measurement Scales 2 (CAIMS 2) scoring before and after physiotherapist-designed aquatic exercise (PDAE) programme
 
Owing to the small sample size and skewed data distribution, medians and the non-parametric Wilcoxon signed rank test were used to compare functional outcomes and CAIMS 2 scores.
 
The medians of the knee range of motion increased from 115° to 125° (P<0.01) after the PDAE, while those for total ROM increased from 120° to 125° (P<0.05). The number of subjects who got end-of-range pain at flexion decreased from 16 to 8 (P<0.05). There was also a marked improvement in the medians for quadriceps strength from 9 kg to 21 kg (P<0.001), FRT from 20 cm to 28 cm (P<0.001), and the repeated sit-to-stand test from 10 to 14 repetitions (P<0.001). There was a slight improvement in the median for the 6-minute walk test (Table 5).
 
There was a significant improvement in mobility level, walking and bending ability of trunk, levels of pain and mood, as well as the total score as measured by CAIMS 2 (Table 6).
 
Discussion
Effectiveness of physiotherapist-designed aquatic exercise programme
Osteoarthritis is associated with muscle atrophy, reduced muscle strength, and decreased ROM. Studies have shown that strength and ROM of women with arthritis are often 70 to 85% that of women of similar age without arthritis.12 Quadriceps weakness is common among patients with OA knee, which is believed to be due to disuse atrophy, as patients tend to unload the painful extremity.3 Osteoarthritis is a common disorder in persons older than 65 years and can significantly affect quality of life.13
 
The goal of the PDAE programme was to improve knee function for the OA-affected knee. In this study, the intervention was associated with a reduction in knee pain, improved strength of knee extensors, improved knee ROM, and overall body balance; all of which were confirmed by improvements in the sit-to-stand test.
 
The advantage of exercising in an aquatic environment is that in comparison to usual weight-bearing exercises, water buoyancy decreases stress on the lower limb joints and surrounding muscles, which provides the ideal medium for pain and stiffness relief from arthritis. Turbulence and its dynamic resistance is another property that can strengthen all muscle groups surrounding the knee, and improve proprioception and body balance.5
 
The results of this study were concordant with the mentioned benefits of the multi-direction resistance provided by the water environment, such that PDAE strengthens the quadriceps effectively. The increased muscle strength around affected joints is a clinically important outcome, as muscles provide shock-absorbing capacity and joint stability to help preserve the diseased joint.4 The decrease in knee joint girth might be explained by reduced swelling and the proximal lift from muscle bulk of the quadriceps and hamstrings due to improved muscle tone.
 
Moreover, the turbulence of water not only provides resistance but also a multi-directional balance challenge. The aquatic environment enables subjects with intrinsic fall risk factors to exercise safely in functional positions. In this study, improvements in trunk movement ability were also noted in the CAIMS 2 questionnaire. The above factors may be the main reasons for improvement in functional balance. In this study, the medians of the subjects’ FRT test results after PDAE improved from a moderate level of fall risk to a less risky level. This change concurs with Simmons and Hansen’s findings,13 whereby greater improvement in functional reach occurred in subjects who had exercised in an aquatic environment. Challenges to balance in an aquatic environment appear to improve dynamic standing balance on land. This is further supported by motor learning literature, where learners demonstrated the ability to apply what they had learnt from different practice conditions and/or movement skills.14 Standing balance training, if sufficiently dynamic in nature, may also improve the performance of functional activities that combine elements of dynamic balance and overall mobility.14 Overall, the functional movement of the knee reflected by the sit-to-stand test also improved.
 
The improvements in the mentioned domains of knee function were contributed to by decreased knee pain after the programme. In reference to the self-management of the knee symptoms, subjects mainly used analgesic ointment and patches. Before the PDAE programme, they might not have realised that exercise was an effective means of improving their knee pain and function. The PDAE programme benefits subjects via performance of suitable exercise so that they are less dependent on drugs and hence drug-induced adverse effects can be reduced.
 
Moreover, the present study showed that PDAE had added benefits on both the physical and psychological aspects of patients with OA knee. Group interaction and socialisation resulting from the interventions may also have influenced psychological domains positively.13 Our results were consistent with findings of other investigators, who noted improvements in clinically active joint function after hydrotherapy but not after a land-based exercise programme.5 Although there was a deterioration in the medians of the sub-score of social activities in CAIMS 2 (P=0.243), this might have been because the latter questionnaire focused on the frequency of getting in touch with friends or relatives, rather than about social activities resulting from the intervention.
 
Although nearly all subjects undertook exercise and on a daily basis before the programme, there was ample scope for improvement in the physical domains for their knees. This might suggest that different types of exercise, including aquatic exercise, should be performed as part of any exercise programme. Besides, measures should be introduced to reduce risk factors for OA knee, such as weight control by means of diet, exercise, and education.
 
Feasibility of physiotherapist-designed aquatic exercise programme
The observed positive effects and the high (96%) overall attendance rate showed that the PDAE programme was highly acceptable even for a community-dwelling elderly population. This compares very favourably to an attendance rate of 40 to 55% usually achieved in exercise programmes for persons with arthritis.15 Satisfactory compliance could be because those who joined the programme could be non-swimmers, and the programme was relatively short in duration (10 weeks). Moreover, it was conducted during relatively warm months in a training pool provided with temperature control by radiators (room temperature ranged between 19°C and 29°C), resulting in an environment warm enough for elders to exercise. Finally, there was good rapport between the subjects and the physiotherapists. Timely advice, support, and encouragement by the physiotherapists might also encourage the subjects to adhere to the programme schedule. Although these components were not evaluated in the programme, one might speculate that emphasis on these aspects helped attain the high degree of compliance.
 
During the recruitment period and implementation of the PDAE, no difficulties or adverse effects were encountered. The subjects found the exercise intensity of the PDAE suitable (mean rate of perceived exertion = 3.3 ± 1.3). Also, all the participants were satisfied with the programme and accepted its benefits, particularly as the PDAE was feasible for implementation in public swimming pool within a community setting.
 
Limitation
A major limitation of this study was the lack of a control group. Therefore, there was no yardstick for comparing the effects of the PDAE with no intervention. Secondly, comparison of outcome measures before and after PDAE could have been influenced by co-interventions (eg use of massage, improvements in posture during daily activities, performance of other types of muscle-strengthening exercises). Moreover, the subjects recruited from EHCs might well be more motivated and health conscious than others. Thirdly, the outcomes were measured without blinding, such that there was always some measurement bias. Finally, the relatively small sample size and recourse to convenience sampling may have conferred imprecision and bias.
 
The benefits of aquatic exercise were already well established in other studies. Our study confirmed its effectiveness for OA knee, specifically in a public swimming pool within a community setting. Furthermore, the experience we gained was valuable for the conduct of any future aquatic exercise programme in the community.
 
Conclusions
The PDAE showed appreciable benefits in terms of reducing knee pain, and improving knee function, body balance, and the psychosocial health of elders with OA knee, including non-swimmers. Populations with OA knee problems and with or without those related to weight-bearing exercise benefited from aquatic exercise. The results justify continuing investment in aquatic exercise programmes as one of the strategies to enhance long-term self-management for elders with chronic OA knee.
 
References
1. The Chinese University of Hong Kong. Osteoarthritis in Hong Kong Chinese—Prevalence, aetiology and prevention [press release]; 2001. Available from: www.cuhk.hk/ipro/010306e.htm. Accessed Sep 2004.
2. Elderly Health Service, Department of Health, Hong Kong. Annual Report 2002.
3. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. Arthritis Rheum 2000;43:1905-15. Crossref
4. Foley A, Halbert J, Hewitt T, Crotty M. Does hydrotherapy improve strength and physical function in patients with osteoarthritis—a randomized controlled trial comparing a gym-based and a hydrotherapy-based strengthening program. Ann Rheum Dis 2003;62:1162-7. Crossref
5. Geytenbeek J. Evidence for effective hydrotherapy. Physiotherapy 2002;88:514-29. Crossref
6. Hall J, Skevington SM, Maddison PJ, Chapman K. A randomized and controlled trial of hydrotherapy in rheumatoid arthritis. Arthritis Care Res 1996;9:206-15. Crossref
7. Minor MA, Hewett JE, Webel RR, Anderson SK, Kay DR. Efficacy of physical conditioning exercise in patients with rheumatoid arthritis and osteoarthritis. Arthritis Rheum 1989;32:1396-405. Crossref
8. Wyatt FB, Milam S, Manske RC, Deere R. The effects of aquatic and traditional exercise programs on persons with knee osteoarthritis. J Strength Cond Res 2001;15:337-40. Crossref
9. Chu EM, Chiu KY, Wong RW, Tong WM, Lau CS. Translation and validation of Arthritis Impact Measurement Scales 2 into Chinese: CAIMS 2. Arthritis Rheum 2004;51:20-7. Crossref
10. Enright PL, McBurnie MA, Bittner V, et al. The 6-min walk test: a quick measure of functional status in elderly adults. Chest 2003;123:387-98. Crossref
11. Ducan PW, Studenski S, Chandler J, Prescott B. Functional reach: predictive validity in a sample of elderly male veterans. J Gerontol 1992;47:M93-8. Crossref
12. Ekdahl C, Broman G. Muscle strength, endurance, and aerobic capacity in rheumatoid arthritis: a comparative study with healthy subjects. Ann Rheum Dis 1992;51:35-40. Crossref
13. Simmons V, Hansen PD. Effectiveness of water exercise on postural mobility in the well elderly: an experimental study on balance enhancement. J Gerontol A Biol Sci Med Sci 1996;51:M233-8. Crossref
14. Rose DJ, Clark S. Can the control of bodily orientation be significantly improved in a group of older adults with a history of falls? J Am Geriatr Soc 2000;48:275-82.
15. Dexter PA. Joint exercises in elderly persons with symptomatic osteoarthritis of the hip or knee. Performance patterns, medical support patterns, and the relationship between exercising and medical care. Arthritis Care Res 1992;5:36-41. Crossref

Benchtop study of leakages across the Portex, TaperGuard, and Microcuff endotracheal tubes under simulated clinical conditions

Hong Kong Med J 2014;20:7–15 | Number 1, February 2014 | Epub 22 Jul 2013
DOI: 10.12809/hkmj133930
© Hong Kong Academy of Medicine. CC BY-NC-ND 4.0
 
ORIGINAL ARTICLE
Benchtop study of leakages across the Portex, TaperGuard, and Microcuff endotracheal tubes under simulated clinical conditions
Arthur CW Lau, FHKAM (Medicine); SM Lam, FHKAM (Medicine); WW Yan, FHKAM (Medicine)
Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong
 
Corresponding author: Dr ACW Lau (laucw3@ha.org.hk)
Abstract
Objectives: To compare three endotracheal tubes for leakage across the cuff (microaspiration) under a comprehensive set of simulated clinical situations. These were the Mallinckrodt TaperGuard (Covidien, US) with a tapered polyvinyl chloride cuff; the KimVent Microcuff (Kimberly-Clark Health Care, US) with a cylindrical polyurethane cuff; and a conventional Portex (Smiths Medical International Ltd, UK) with a globular polyvinyl chloride cuff.
 
Design: A benchtop experimental study.
 
Setting and materials: A silicone cylinder serving as the model trachea was intubated with each of the three endotracheal tubes, one at a time. A total of 20 mL of water were added above the cuff and leakage measured every minute for 20 minutes under five simulated mechanical ventilation scenarios, including different positive end-expiratory pressure levels, and disconnection with and without spontaneous breathing efforts. Each scenario was studied under three cuff pressures of 10, 20 and 30 cm H2O, and then repeated with the application of a continuous suction force of 200 cm H2O, and leakage measured every minute for 3 minutes.
 
Results: The outcome of interest was the cumulative amount of leakage. The Microcuff endotracheal tubes with an ultrathin polyurethane cuff consistently provided the best protection against microaspiration under all simulated clinical situations, followed by TaperGuard with a tapered cuff, and lastly Portex with a globular polyvinyl chloride cuff. Clinical scenarios associated with the greatest leakage were mechanical ventilation with zero positive end-expiratory pressure, circuit disconnection with spontaneous breathing efforts, application of suction, and a low cuff pressure.
 
Conclusions: Microcuff endotracheal tubes outperformed TaperGuard and Portex endotracheal tubes in preventing microaspiration, which is one of the major mechanisms for ventilator-associated pneumonia.
 
 
New knowledge added by this study
  • Microcuff endotracheal tubes (ETTs) with an ultrathin polyurethane cylindrical cuff provided the best protection against microaspiration under diverse situations.
  • TaperGuard ETT with a tapered polyvinyl chloride (PVC) cuff provided protection against microaspiration in simulated at-risk situations, given that the cuff pressure was maintained at the recommended 20 to 30 cm of H2O.
  • The most widely used Portex ETT with a globular PVC cuff did not protect against microaspiration under these at-risk simulated situations, even at recommended cuff pressures of 20 to 30 cm H2O.
Implications for clinical practice or policy
  • This study supports more widespread use of ETTs with an ultrathin polyurethane cuff (eg the Microcuff) to better prevent microaspiration, which is one of the major mechanisms of ventilator-associated pneumonia.
  • Some scenarios appear more prone to microaspirations, eg zero positive end-expiratory pressure, total disconnection, and spontaneous breathing. The Microcuff ETT outperformed other ETTs, particularly in such scenarios.
 
Introduction
One of the major mechanisms of ventilator-associated pneumonia (VAP) is microaspiration of bacteria-colonised oropharyngeal secretions that collect above the inflated cuff of the endotracheal tube (ETT). In Hong Kong, for several decades, the cuff of the most commonly used ETT has been made of polyvinyl chloride (PVC) and has a globular shape. This type of cuff protects against microaspiration poorly, due to microchannels formed from infolding of redundant cuff material after inflation.1 Novel designs of the ETT cuff attempt to overcome this problem by modifying the material from the thicker (50- to 80-micron) PVC to the ultrathin (10-micron) polyurethane (PU),2 and the cuff shape from globular to tapered or cylindrical. In addition, a subglottic secretion drainage port for aspiration of secretions collected above the cuff is available in some ETTs. Although these novel ETTs have been available for many years,3 4 they are not widely used locally. Reasons include inadequate cost-effectiveness data, even though most studies reported favourable efficacy in reducing VAP, though not necessarily mortality.1
 
Many previous benchtop studies have shown the benefits of these novel designs, but mostly under a limited number of conditions, or under a static condition without the dynamic effect of different levels of positive pressures from mechanical ventilation or negative pressures associated with spontaneous breathing and/or suction.5 6 Moreover, they mostly reported the amount of leakage at a particular time point without showing continuous trends.5 The aim of the present study was to compare these novel ETTs under a comprehensive set of simulated clinical conditions, and to find the bestperforming tube in which downward leakage of fluid across the cuff was minimal.
 
Methods
The experimental setup is shown in Figure 1. The three types of ETTs under test were the Portex Endotracheal Tube (Smiths Medical International Ltd, UK) with a globular PVC cuff; the Mallinckrodt TaperGuard Endotracheal Tube (Covidien, US) with a tapered PVC cuff; and the KimVent Microcuff Endotracheal Tube (Kimberly-Clark Health Care, US) with a cylindrical PU cuff (Fig 2). A transparent, hollow silicone cylinder of length 20 cm and an internal diameter of 2 cm was used as the model trachea. An internal diameter of 2 cm was chosen because from autopsy studies, the mean diameters of male and female tracheas were 2.2 cm and 1.8 cm, respectively.7 A flexible and extensible tube was added to the proximal end of the model trachea to prevent fluid from splashing out where significant upward leakage results from high positive ventilatory pressure.5 The ETT under study was connected to a SERVO-i Adult ventilator (Maquet GmbH & Co. KG, Germany). The model trachea was inclined at 35 degrees to the horizontal to simulate the semi-recumbent position for VAP prevention. Cuff pressure (Pcuff) was maintained by an automated maintenance setup as devised and modified from a previous study.8 In short, compressed air in the range of 2 to 3 L/min was used to inflate the cuff and the pressure was altered with a leakage port along the circuit, to maintain the desired Pcuff within a range of ± 1 cm H2O at end-expiration. The PVC cuff was monitored continuously using a calibrated electronic pressure transducer (Model HCLA0050EU; Sensortechnics GmbH, Germany), with signals digitally transformed by an analogue-to-digital converter (NI USB-6212; National Instruments, US), so as to display on a computer using the LabVIEW 2010 software (National Instruments Corporation, US). The proximal end of a Y-piece was connected to the distal end of the model trachea. To the Y-piece’s vertical end, a water trap made of a 20-mL syringe was connected. For the study of positive pressure mechanical ventilation, it was connected to a lung simulator (SMS Lung Simulator; SMS Technologies, UK) at its distal end. For the study of spontaneous breathing, it was connected to a Huszczuk-Whipp-Wasserman Gas Exchange System Validator (MedGraphics, US)9 which generated breaths to mimic different metabolic rates; and for the study of total disconnection, it was opened to atmospheric pressure.
 

Figure 1. Graphical representation of the experimental setup
 

Figure 2. The three types of endotracheal tubes (ETTs) tested (8-mm internal diameter)
 
The scenarios simulated are shown in Table 1. Clear water (20 mL) was added above the ETT cuff. The whole process was recorded by a video recorder and leakage was measured as observed in the syringe for 20 minutes. Each scenario was studied under different Pcuffs of 10, 20, and 30 cm H2O. For each scenario at each Pcuff, two tubes of the same ETT type were tested, and each tube was studied repeatedly for 4 times, therefore making a total of 8 measurements for each ETT type per scenario and Pcuff.
 

Table 1. Simulated clinical scenarios tested under three different cuff pressures (10, 20, and 30 cm H2O) using the three types of endotracheal tubes (ETTs)
 
The same scenarios were then repeated under sustained tracheal suction by placing a suction catheter (12-Fr closed suction catheter) inside the ETT near the Murphy eye,10 and a suction pressure of 200 cm H2O was applied continuously for 3 minutes.
 
The primary measurement was the downward leakage across the cuff, defined as the amount of fluid collected in the syringe (the fluid trap) every minute during the observation period.
 
Statistical analysis
Between- and within-group analysis of variance (ANOVA) was used for analysis of the amount of downward leakage during the whole observation period, with the aim of comparing the difference in leakage between the three types of ETTs for each scenario. Each scenario at each Pcuff was analysed separately, in which between-group data were different types of ETTs and within-group data were the cumulative amount (in mL) of leakage over each observation period. Statistical analysis was performed using IBM SPSS software version 20 (SPSS, Inc, IBM, US).
 
Results
Results of the five scenarios without suction (1NS to 5NS) are shown in Figure 3. The P values represent analyses by ANOVA of the cumulative leakage over the whole 20-minute observation period. The cumulative leakages at the 20-minute time point are shown in Table 2. In summary, in scenario 1NS (positive end-expiratory pressure [PEEP] of 0 cm H2O), the Microcuff outperformed the other two ETTs at all Pcuffs. At a Pcuff of 30 cm H2O, only the Portex showed leakage, which was early and massive. At a Pcuff of 20 cm H2O, only Microcuff did not leak. At a Pcuff of 10 cm H2O, all three ETTs leaked, but the rate was fastest in Portex and lowest in Microcuff. In scenario 2NS (PEEP of 5 cm H2O), at Pcuffs of 30 and 20 cm H2O, all three ETTs showed no leakage, while at a Pcuff of 10 cm H2O, only Portex showed minimal leakage. In scenario 3NS (PEEP of 10 cm H2O), none leaked. In scenario 4NS (disconnection), significant leakage occurred only in Portex at Pcuffs of 30 and 20 cm H2O. At a Pcuff of 10 cm H2O, all leaked, but the rate was lowest with Microcuff. In scenario 5NS (spontaneous breathing), addition of spontaneous breathing led to leakage in all ETTs at Pcuffs of 10 and 20 cm H2O, but the rate remained the lowest in Microcuff. At a Pcuff of 30 cm H2O, only Microcuff showed minimal leakage.
 

Figure 3. Downward leakage in the model trachea in the five scenarios without suction (1NS to 5NS)
 

Table 2. Cumulative leakage at the 20-minute time point for different scenarios*
 
Results of the five scenarios with suction (1S to 5S) are shown in Figure 4. The P values pertained to analyses by ANOVA of the whole 3-minute observation period. The cumulative leakages at the 3-minute time point are shown in Table 2. In summary, in scenario 1S (PEEP of 0 cm H2O), at Pcuffs of 30 and 20 cm H2O, only Microcuff was protective, while the other two leaked almost instantly. At a Pcuff of 10 cm H2O, all three ETTs leaked, but Microcuff leaked very slowly. In scenario 2S (PEEP of 5 cm H2O), at a Pcuff of 30 cm H2O, leakage occurred instantly with Portex, in contrast to zero leakage in the corresponding scenario without suction. At a Pcuff of 20 cm H2O, only Microcuff did not leak. At a Pcuff of 10 cm H2O, all three ETTs leaked, but Microcuff leaked very slowly. In scenario 3S (PEEP of 10 cm H2O), at a Pcuff of 30 cm H2O, none leaked. At a Pcuff of 20 cm H2O, minimal leakage occurred with Portex. In scenario 4S (disconnection), at a Pcuff of 30 cm H2O, significant leakage was found in Portex. At a Pcuff of 20 cm H2O, only Microcuff was protective whilst TaperGuard leaked slowly. At a Pcuff of 10 cm H2O, Microcuff was still protective with minimal leakage at 3 minutes. In scenario 5S (spontaneous breathing), at a Pcuff of 30 cm H2O, significant leakage was found in Portex. At a Pcuff of 20 cm H2O, Portex leaked significantly, TaperGuard leaked very slowly, while Microcuff was protective. At a Pcuff of 10 cm H2O, all three leaked.
 

Figure 4. Downward leakage in the model trachea in the five scenarios after application of continuous suction of 200 cm H2O for 3 minutes (1S to 5S)
 
Discussion
The present benchtop study showed that under the various simulated scenarios studied (positive pressure ventilation, disconnection, spontaneous breathing, with or without the application of suction), the Microcuff ETT consistently outperformed the others with the least downward leak and the lowest sealing pressure, whereas the TaperGuard ETT was in second place. The Portex ETT performed the worst, with significant leakage whenever there was a loss of positive airway pressure even at the recommended Pcuffs of 20 to 30 cm H2O.
 
Among the limitations of the present study, many in-vivo factors were not or could not be fully simulated but might have affected the leakage rate. In-vivo leakage could be greater when there is a change in tracheal dimensions during inspiration and/or imperfect conformation of the circular cuff to the trachea (which could have different anteroposterior compared with transverse dimensions), and when there is a sudden change in airway pressure or the cuff position inside the trachea as the patient coughs or moves. Moreover, the seal between the cuff and the moist tracheal mucosa might actually be better, especially with the use of lubricant at the time of intubation.4 11 12 The upward sweeping movement of the ciliated mucosa might also decrease aspiration. Furthermore, subglottic collections are more viscous than water, and their volume is not likely to be as high as 20 mL. This volume was chosen in the current experiment to better discriminate ETT performance and minimise measurement errors. Dynamic patient factors may also affect leakage. For example, leakage in the first scenario (zero PEEP) might be less if significant auto-PEEP develops in severe airflow obstruction, and the size of the cuff relative to the trachea might increase or decrease leakage. Nor did we test the effect of subglottic suction, which is extremely effective in removing fluid collected above the cuff. However, the effectiveness of subglottic suction might differ in vivo, depending on the viscosity of secretions and apposition of the posterior mucosal wall obstructing the suction lumen and interfering with such efforts.13 According to guidelines on endotracheal suction for adults,14 the lowest suction pressure that can effectively clear secretions should be used, which should not exceed 150 cm H2O, and for not more than 15 seconds. We deliberately used sustained suction at 200 cm H2O for 3 minutes to better discriminate the performance of each ETT. Notably though, in the present experiment it was observed that leakage occurred within the first second of suction. Although it can be argued that a 20-minute observation period may be too short, we found that prolonging this period led to excessive evaporation of the water above the cuff. We did not use coloured water because we measured water collected in the syringe, simulating the volume of fluid actually aspirated into the lower airway, and not the minute amounts that might just leak and stay around the cuff. Fluid more viscous than water was not used because firstly, human secretions can never be fully simulated, and secondly, should there be any leakage, fluid of a lower viscosity (like water) was considered more liable to leak. Furthermore, the need for thorough cleansing of viscous fluid by dismantling the connections of the apparatus after each set of experiments was another consideration. Such cleansing was regarded as not feasible, because each connection needed to be secured with glue and tapes to withstand the high positive airway pressure and this would take an unrealistic amount of time to do so repeatedly.
 
The present experiment clearly discriminated the performance characteristics of the three ETTs. Infolding of the excess and thick PVC material in the Portex ETT formed micro-channels through which leakage occurred. By modifying the cuff to a tapered shape, leakage in the TaperGuard ETT was minimised, as there was a point along the length of the cuff where it fitted the trachea perfectly without the infolding of excess cuff material. In the Microcuff ETT, infolding of excess cuff material was still observed. However, micro-channels were not formed because of the much thinner PU material. Its cylindrical shape also provided a larger contact area between the cuff and tracheal wall, thus providing a better seal than the other two types of ETTs.
 
One of the clinical implications of our findings was that PEEP guards against downward leakage across cuffs, irrespective of the ETT type and Pcuff. In a previous study, it was shown that only the application of a 35 cm H2O PEEP prior to cuff deflation at extubation was protective against aspiration, but not open or closed suction (that supposedly removes aspirated water).15 This protective effect of a higher PEEP was independent of the peak inspiratory pressure (PIP) as leakage still occurred in scenario 1NS (with a PIP of 15 cm H2O); such finding was in line with another study showing that only higher PEEP values and not higher inspiratory pressures were protective.16 However, the protective effect of PEEP, especially with low pressures of around 5 cm of H2O, was counteracted by the application of suction, as shown by the appearance of leakage when suction was applied to the Portex and TaperGuard ETTs as in scenario 2S. Another study showed that when suction at 200 or 300 mbar was applied via ETTs with a PVC cuff, leakage could only be reduced by transiently increasing Pcuff to 50 cm H2O, and not at all by increasing the PEEP from 5 to 10 cm H2O or the PIP from 15 to 25 cm H2O.17 This same study also showed that the PU cuff almost eliminated leakage under all suction pressures, and all PEEP or PIP values.17 Therefore, to prevent leakage during suction, a Pcuff of 50 cm H2O may be necessary unless a PU cuff is used, while the suction duration and force should be reduced to a minimum, and routine suction should always be avoided. Given that suctioning results in the loss of PEEP and recruitment manoeuvres are recommended thereafter,14 it may be worth studying whether the application of high PEEP during suction can prevent both derecruitment and leakage across the cuff.
 
Similar to the effect of applying no PEEP during mechanical ventilation, disconnection from such ventilation results in significant leakage across the cuff, and should be avoided as far as possible. Harnessing the portability of an intensive care unit ventilator to avoid circuit disconnections should therefore be considered when patients are transported. When disconnection is necessary, its duration should be kept to a minimum with the maintenance of PEEP. For example, a PEEP valve from a bag-valve device may minimise leakage across the cuff. Spontaneous breathing during disconnection, which creates a negative intrathoracic pressure, further exacerbates downward leakage (scenario 5NS). Another study has also found that leakage increased with increasing inspiratory effort.16 Therefore, during disconnection for spontaneous breathing trials, microaspiration is to be expected if the conventional globular PVC cuff is used. Even with the use of novel ETTs, a high patient inspiratory effort during a trial of spontaneous breathing is conducive to microaspiration and should be anticipated. Extrapolating these results, a high patient inspiratory effort while on mechanical ventilation may prove to be another scenario at high risk of microaspiration.
 
Under situations with a high risk of microaspiration, namely zero or low PEEP, circuit disconnection, in the presence of high patient inspiratory effort and application of a suction force, the type of ETT used will make a difference to the rate of downward leakage. The Microcuff ETT was shown to offer the best protection in these situations. The TaperGuard ETT was protective if a higher Pcuff could be maintained, and a Pcuff maintenance device (keeping it between 20 and 30 cm of H2O) may be helpful. Notably, the most commonly used Portex ETT provided the least protection against microaspiration, and leakage occurred in these situations despite maintaining a Pcuff at the recommended 20 to 30 cm H2O.
 
Based on the findings of the present study, further clinical trials on VAP prevention using novel ETTs less prone to microaspiration are needed. These should control for confounding factors including PEEP, airway suction, use of automated Pcuff maintenance devices, and airway disconnections. At the time of writing, the cost of a Microcuff ETT was around 6 times that of a Portex ETT (HK$68 vs HK$11), and a TaperGuard ETT was around double (HK$20). Although cost-effectiveness analysis is worthwhile as a basis for wider promotion of the novel ETTs, taking into account the small absolute cost difference, there may be a case for just switching ETTs to those with a lesser tendency to leak until evidence to the contrary appears.
 
Conclusions
The present benchtop study showed that a higher PEEP, avoidance of unnecessary circuit disconnections and suctioning, and maintenance of adequate Pcuff are important in minimising microaspiration. The Microcuff ETT was shown to be superior to TaperGuard and Portex ETTs in preventing leakage across the cuff. As microaspiration is one of the major mechanisms of VAP, more widespread use of ETTs with a PU cuff, combined with other prevention measures (eg bedhead elevation, oral hygiene) may help to reduce the frequency of associated pneumonias.
 
Declaration
No conflicts of interest were declared by the authors.
 
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