Status:
COMPLETED
Electrical Stimulation for Critically Ill Covid-19 Patients
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Avazzia, Inc
Conditions:
Covid19
Muscle Atrophy
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
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 mainta...
Detailed Description
Phase I: The purpose of this study is to test feasibility and proof-of-concept effectiveness of lower extremity electrical stimulation (EE) therapy to prevent muscular complications of COVID-19 inclu...
Eligibility Criteria
Inclusion
- COVID-19 test positive critically ill patients in need of assisted ventilation requiring care in the intensive care unit
- COVID-19 test positive critically ill patients in need of assisted ventilation requiring prolonged care in the hospital
Exclusion
- Paralyzed patients (i.e., rocuronium, cisatracurium) at the moment of enrollment
- Patients under vasopressor therapy (i.e., norepinephrine, epinephrine, vasopressin) at the moment of enrollment
- Patients expected to be discharged in the next 24 hours
- Patient 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
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04685213
Start Date
December 22 2020
End Date
March 18 2021
Last Update
February 16 2023
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030