Repetitive vascular occlusion stimulus (RVOS) versus standard care to prevent muscle wasting in critically ill patients (ROSProx):a study protocol for a pilot randomised controlled trial
Abstract Background Forty per cent of critically ill patients are affected by intensive care unit-acquired weakness (ICU-AW), to which skeletal muscle wasting makes a substantial contribution. This can impair outcomes in hospital, and can cause long-term physical disability after hospital discharge....
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| Format: | Article |
| Language: | English |
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BMC
2019-07-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3547-5 |
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| author | Ismita Chhetri Julie E. A. Hunt Jeewaka R. Mendis Stephen D. Patterson Zudin A. Puthucheary Hugh E. Montgomery Benedict C. Creagh-Brown |
| author_facet | Ismita Chhetri Julie E. A. Hunt Jeewaka R. Mendis Stephen D. Patterson Zudin A. Puthucheary Hugh E. Montgomery Benedict C. Creagh-Brown |
| author_sort | Ismita Chhetri |
| collection | DOAJ |
| description | Abstract Background Forty per cent of critically ill patients are affected by intensive care unit-acquired weakness (ICU-AW), to which skeletal muscle wasting makes a substantial contribution. This can impair outcomes in hospital, and can cause long-term physical disability after hospital discharge. No effective mitigating strategies have yet been identified. Application of a repetitive vascular occlusion stimulus (RVOS) a limb pressure cuff inducing brief repeated cycles of ischaemia and reperfusion, can limit disuse muscle atrophy in both healthy controls and bed-bound patients recovering from knee surgery. We wish to determine whether RVOS might be effective in mitigating against muscle wasting in the ICU. Given that RVOS can also improve vascular function in healthy controls, we also wish to assess such effects in the critically ill. We here describe a pilot study to assess whether RVOS application is safe, tolerable, feasible and acceptable for ICU patients. Methods This is a randomised interventional feasibility trial. Thirty-two ventilated adult ICU patients with multiorgan failure will be recruited within 48 h of admission and randomised to either the intervention arm or the control arm. Intervention participants will receive RVOS twice daily (except only once on day 1) for up to 10 days or until ICU discharge. Serious adverse events and tolerability (pain score) will be recorded; feasibility of trial procedures will be assessed against pre-specified criteria and acceptability by semi-structured interview. Together with vascular function, muscle mass and quality will be assessed using ultrasound and measures of physical function at baseline, on days 6 and 11 of study enrolment, and at ICU and hospital discharge. Blood and urine biomarkers of muscle metabolism, vascular function, inflammation and DNA damage/repair mechanism will also be analysed. The Health questionnaire will be completed 3 months after hospital discharge. Discussion If this study demonstrates feasibility, the derived data will be used to inform the design (and sample size) of an appropriately-powered prospective trial to clarify whether RVOS can help preserve muscle mass/improve vascular function in critically ill patients. Trial registration ISRCTN Registry, ISRCTN44340629. Registered on 26 October 2017. |
| first_indexed | 2024-04-13T03:01:52Z |
| format | Article |
| id | doaj.art-b5b69c1a64c6448ab3c10e202bc48e07 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T03:01:52Z |
| publishDate | 2019-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-b5b69c1a64c6448ab3c10e202bc48e072022-12-22T03:05:24ZengBMCTrials1745-62152019-07-0120111410.1186/s13063-019-3547-5Repetitive vascular occlusion stimulus (RVOS) versus standard care to prevent muscle wasting in critically ill patients (ROSProx):a study protocol for a pilot randomised controlled trialIsmita Chhetri0Julie E. A. Hunt1Jeewaka R. Mendis2Stephen D. Patterson3Zudin A. Puthucheary4Hugh E. Montgomery5Benedict C. Creagh-Brown6Intensive Care Unit, Royal Surrey County Hospital NHS Foundation TrustFaculty of Health and Medical Sciences, School of Biosciences and Medicine, University of SurreyFaculty of Health and Medical Sciences, School of Biosciences and Medicine, University of SurreyFaculty of Sport, Health and Applied Science, St Mary’s UniversityWilliam Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of LondonInstitute for Sport, Exercise and Health, University College LondonIntensive Care Unit, Royal Surrey County Hospital NHS Foundation TrustAbstract Background Forty per cent of critically ill patients are affected by intensive care unit-acquired weakness (ICU-AW), to which skeletal muscle wasting makes a substantial contribution. This can impair outcomes in hospital, and can cause long-term physical disability after hospital discharge. No effective mitigating strategies have yet been identified. Application of a repetitive vascular occlusion stimulus (RVOS) a limb pressure cuff inducing brief repeated cycles of ischaemia and reperfusion, can limit disuse muscle atrophy in both healthy controls and bed-bound patients recovering from knee surgery. We wish to determine whether RVOS might be effective in mitigating against muscle wasting in the ICU. Given that RVOS can also improve vascular function in healthy controls, we also wish to assess such effects in the critically ill. We here describe a pilot study to assess whether RVOS application is safe, tolerable, feasible and acceptable for ICU patients. Methods This is a randomised interventional feasibility trial. Thirty-two ventilated adult ICU patients with multiorgan failure will be recruited within 48 h of admission and randomised to either the intervention arm or the control arm. Intervention participants will receive RVOS twice daily (except only once on day 1) for up to 10 days or until ICU discharge. Serious adverse events and tolerability (pain score) will be recorded; feasibility of trial procedures will be assessed against pre-specified criteria and acceptability by semi-structured interview. Together with vascular function, muscle mass and quality will be assessed using ultrasound and measures of physical function at baseline, on days 6 and 11 of study enrolment, and at ICU and hospital discharge. Blood and urine biomarkers of muscle metabolism, vascular function, inflammation and DNA damage/repair mechanism will also be analysed. The Health questionnaire will be completed 3 months after hospital discharge. Discussion If this study demonstrates feasibility, the derived data will be used to inform the design (and sample size) of an appropriately-powered prospective trial to clarify whether RVOS can help preserve muscle mass/improve vascular function in critically ill patients. Trial registration ISRCTN Registry, ISRCTN44340629. Registered on 26 October 2017.http://link.springer.com/article/10.1186/s13063-019-3547-5Repetitive vascular occlusion stimulusICU-acquired weaknessBlood flow restrictionCritical illnessRehabilitationMuscle atrophy |
| spellingShingle | Ismita Chhetri Julie E. A. Hunt Jeewaka R. Mendis Stephen D. Patterson Zudin A. Puthucheary Hugh E. Montgomery Benedict C. Creagh-Brown Repetitive vascular occlusion stimulus (RVOS) versus standard care to prevent muscle wasting in critically ill patients (ROSProx):a study protocol for a pilot randomised controlled trial Trials Repetitive vascular occlusion stimulus ICU-acquired weakness Blood flow restriction Critical illness Rehabilitation Muscle atrophy |
| title | Repetitive vascular occlusion stimulus (RVOS) versus standard care to prevent muscle wasting in critically ill patients (ROSProx):a study protocol for a pilot randomised controlled trial |
| title_full | Repetitive vascular occlusion stimulus (RVOS) versus standard care to prevent muscle wasting in critically ill patients (ROSProx):a study protocol for a pilot randomised controlled trial |
| title_fullStr | Repetitive vascular occlusion stimulus (RVOS) versus standard care to prevent muscle wasting in critically ill patients (ROSProx):a study protocol for a pilot randomised controlled trial |
| title_full_unstemmed | Repetitive vascular occlusion stimulus (RVOS) versus standard care to prevent muscle wasting in critically ill patients (ROSProx):a study protocol for a pilot randomised controlled trial |
| title_short | Repetitive vascular occlusion stimulus (RVOS) versus standard care to prevent muscle wasting in critically ill patients (ROSProx):a study protocol for a pilot randomised controlled trial |
| title_sort | repetitive vascular occlusion stimulus rvos versus standard care to prevent muscle wasting in critically ill patients rosprox a study protocol for a pilot randomised controlled trial |
| topic | Repetitive vascular occlusion stimulus ICU-acquired weakness Blood flow restriction Critical illness Rehabilitation Muscle atrophy |
| url | http://link.springer.com/article/10.1186/s13063-019-3547-5 |
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