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. 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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3547-5) contains supplementary material, which is available to authorized users.

The effect of passive mobilization associated with blood flow restriction and combined with electrical stimulation on cardiorespiratory safety, neuromuscular adaptations, physical function, and quality of life in comatose patients in an ICU: a randomized controlled clinical trial

“…In addition to using an innovative combination, the experimental design was modified from the intra-subject design, used by previous studies in the field such as Dirks et al [ 59 ], Barbalho et al [ 37 ], and Chhetri et al [ 51 ], to an inter-subject design. The inter-subject design enables the application of protocols bilaterally, simultaneously, and alternately, which allows the replication of the intensive care clinical practice and preserves the ecological validity and investigation of the maximized effects of training on muscle atrophy and weakness, functional responses, and outcome of quality of life of ICU coma surviving patients.…”

“…To assess cardiovascular safety, HR values < 50 bpm or > 180 bpm, SBP < 80 mmHg or > 160 mmHg, DBP < 60 mmHg or > 80 mmHg, MAP < 60 mmHg or > 120 mmHg, cardiac or respiratory arrythmias, SpO 2 < 88%, signals of respiratory discomfort [ 50 , 51 ], or signals of deep venous thrombosis will be considered criteria to interrupt the protocol. Except for the occurrence of deep venous thrombosis, two consecutive training attempts will be performed after the first training interruption before withdrawing the patient from the study.…”

“…After T1, in view of the cardiovascular safety and applicability of PM, BFRp, and BFRpE, training sessions will be held twice a day, divided by 4 h [ 51 ]. The starting training leg will be randomly chosen at T1 and, from that, alternated in every training session.…”

“…Additionally, for the VL, the anatomical reference will be the middle portion between the great trochanter and the lateral epicondyle [ 68 ]. For RF, the reference will be set at 50% and at two-thirds of the distance from the anterior superior iliac spine and the superior patella border [ 51 , 69 ]. Anatomical references for AT will be defined in one-fourth of the distance between the inferior portion of the patella and the lateral malleolus and one-third of the distance between the border of the fibula and the medial malleolus [ 70 ].…”

“…Six muscle groups of the upper and lower limbs will be assessed bilaterally through the global strength (shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and feet dorsiflexors) by the MRC score [ 51 , 74 , 75 ]. Test familiarization will be performed through passive movements, and the tests will be applied in a fixed order.…”