Electrical Stimulation for Critically Ill Covid-19 Patients
Electrical Stimulation for Critically Ill Covid-19 Patients
Unfortunately, hospital-acquired weakness is highly prevalent among COVID-19 hospitalized
 patients, who often require prolonged bed-rest or paralytics for an extended period of time
 in order to maintain oxygenation. Prolonged bed rest has been associated with pronounced loss
 of muscle mass that can exceed 10% over the 1st week, which leads to functional impairment
 and complications post-hospital discharge. Physical therapy and in-hospital mobility program
 may reduce the incident of hospital-acquired weakness, but they are often impractical for
 COVID-19 patients. In particular, conventional mobility programs are challenging for those
 who are being treated in an intensive Care Unit. The purpose of this study is to test
 feasibility and proof-of-concept effectiveness of daily use of lower extremity electrical
 stimulation (EE) therapy, as a practical solution to retain lower extremity muscle mass, to
 address chronic morbid consequences of COVID-19 including hospital-acquired weakness.
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.
Inclusion Criteria:

 -  COVID-19 test positive critically ill non-paralized patients in need of mechanical
 ventilation requiring care in the intensive care unit

 Exclusion Criteria:

 -  Subject has a demand-type cardiac pacemaker, implanted defibrillator or other
 implanted electronic device.

 -  Active wound infection

 -  Below the knee amputations

 -  Based on the clinicians decision whether the patient is eligible for the study