Electrical Stimulation for Critically Ill Covid-19 Patients

Summary

Participation Requirements

Description

The purpose of this study is to test feasibility and proof-of-concept effectiveness of lower extremity electrical stimulation (EE) therapy to address chronic morbid consequences of COVID-19 including hospital-acquired weakness and neuropathy. This is a proof of concept randomized control trial (RCT)...

The purpose of this study is to test feasibility and proof-of-concept effectiveness of lower extremity electrical stimulation (EE) therapy to address chronic morbid consequences of COVID-19 including hospital-acquired weakness and neuropathy. This is a proof of concept randomized control trial (RCT) study. Eligible participants (n=20 anticipated) will be recruited from the Baylor St. Luke's' Medical Center (Houston, Texas). To be eligible participants should be hospitalized because of COVID-19 infection and suspected to be at risk for hospital acquired-weakness based on judgment of clinical intensivist investigators. Participants will be excluded if they are paralyzed. Other exclusion criteria include blow the knee amputation, those who have a demand-type cardiac pacemaker, implanted defibrillator or other implanted electronic device; those with wound infection, and other conditions that may interfere with outcomes or increase the risk of the use EE based on judgement of clinicians. The Investigators hypothesize that implementation of EE as means of regular activation of lower extremity muscle is feasible and acceptable for the target population and would help to retain lower extremity muscle mass, lower extremity tissue oxygen saturation and perfusion, and thus reducing the severity of hospital acquired weakness and potentially improve outcomes of treatment among COVID-19 patients. Participants will be randomized to intervention (IG) or control group (CG)). The entire cohort will receive daily EE in lower extremity (e.g. Gastronemius, tibial anterior muscle) up to 1 hour. EE therapy will be provided using a bio-electric stimulation technology (BEST) platform (Tennant Biomodulator PRO®, AVAZZIA, Inc.). The EE device will be functional for IG and non-functional for CG. The primary outcomes include between group difference and change from the baseline in muscle function, muscle strength, lower extremity tissue oxygen saturation, neuropathy, and muscle atrophy. Outcomes will be assessed at baseline, time of discharge or 4 weeks, whichever came first.

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