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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