Electrical Stimulation for Critically Ill Covid-19 Patients (Phase I)
Primary Purpose
Covid19, Muscle Atrophy, Muscle Weakness
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Electrical Stimulation
Electrical Stimulation - Sham
Sponsored by
About this trial
This is an interventional supportive care trial for Covid19 focused on measuring electrical stimulation, skin perfusion, Muscle dysfunction
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active E-Stim
sham E-Stim
Arm Description
Subjects will receive an active electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).
Outcomes
Primary Outcome Measures
Change in Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation
Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).
Change in Ankle Strength
Ankle strength will be measured in response to the average of three 5-second dorsiflexion maximum voluntary isometric contractions per 30 seconds of relaxation in-between using a dynamometer (RoMech Digital Hanging Scale).
Secondary Outcome Measures
Change in Plantar Tissue Oxygen Saturation/Consumption
Percentage of tissue oxygen saturation (SatO2) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 level in superficial tissue. The metatarsus area including the five toes will be traced.
Full Information
NCT ID
NCT04685213
First Posted
December 23, 2020
Last Updated
February 14, 2023
Sponsor
Baylor College of Medicine
Collaborators
Avazzia, Inc
1. Study Identification
Unique Protocol Identification Number
NCT04685213
Brief Title
Electrical Stimulation for Critically Ill Covid-19 Patients
Acronym
Phase I
Official Title
Electrical Stimulation Therapy for Preventing Hospital-acquired Weakness in Critically Ill COVID-19 Patients - A Proof of Concept Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
March 18, 2021 (Actual)
Study Completion Date
March 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Avazzia, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 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 address lower extremity muscle deconditioning, to address chronic consequences of COVID-19 including hospital-acquired weakness.
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 including hospital-acquired weakness and neuropathy. This is a proof of concept randomized control trial (RCT) study for prevention. Eligible participants (n=19 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 endurance, muscle strength, lower extremity tissue oxygen saturation, neuropathy, and muscle atrophy. Outcomes will be assessed at baseline, time of discharge or 2 weeks, whichever comes first.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Muscle Atrophy, Muscle Weakness
Keywords
electrical stimulation, skin perfusion, Muscle dysfunction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to intervention (IG) or control group (CG) with ratio of 1:1. The entire cohort will receive daily electrical stimulation (EE) in lower extremity (e.g. Gastronemius muscle) for up to 1 hour. The EE device will be functional for IG and non-functional for CG.
Phase I will include patients (n=19) admitted to the hospital due to severe COVID-19 infection. The time frame for therapy will be 2 weeks or until hospital discharge, whichever comes first.
Masking
ParticipantCare Provider
Masking Description
Devices may be active or sham.
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active E-Stim
Arm Type
Active Comparator
Arm Description
Subjects will receive an active electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).
Arm Title
sham E-Stim
Arm Type
Sham Comparator
Arm Description
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).
Intervention Type
Device
Intervention Name(s)
Electrical Stimulation
Intervention Description
Subjects will receive an active electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).
Intervention Type
Device
Intervention Name(s)
Electrical Stimulation - Sham
Intervention Description
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).
Primary Outcome Measure Information:
Title
Change in Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation
Description
Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).
Time Frame
an average of 2 weeks (Phase I)
Title
Change in Ankle Strength
Description
Ankle strength will be measured in response to the average of three 5-second dorsiflexion maximum voluntary isometric contractions per 30 seconds of relaxation in-between using a dynamometer (RoMech Digital Hanging Scale).
Time Frame
an average of 2 weeks (Phase I)
Secondary Outcome Measure Information:
Title
Change in Plantar Tissue Oxygen Saturation/Consumption
Description
Percentage of tissue oxygen saturation (SatO2) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 level in superficial tissue. The metatarsus area including the five toes will be traced.
Time Frame
an average of 2 weeks (Phase I)
Other Pre-specified Outcome Measures:
Title
Likelihood of Falling
Description
Assessment via the total score of Morse Fall Scale, which is the sum of six variables' score depending on presence or absence of:
History of falling: Score 25 for falls during the present hospital admission or immediate history of physiological falls; if not, score 0.
Secondary diagnosis: 15 if there is more than one medical diagnosis; if not, score 0.
Ambulatory aids: 0 for walking without a walking aid, uses wheelchair, or is on bedrest; 15 for use of crutches, a cane, or a walker; 30 for ambulation clutching onto the furniture for support.
Intravenous therapy: 20 for intravenous apparatus or a heparin lock inserted; if not, score 0.
Gait: 0 if has a normal gait; 10 weak gait; 20 impaired gait.
Mental status: patient's own self-assessment; 0 if normal; 15 if impaired.
Scale:
Minimum score or low risk: < 24 points Medium score or Moderate risk: 25-45 points Maximum score or high risk: > 45 points.
Time Frame
an average of 2 weeks (Phase I)
Title
Change in Gastrocnemius Muscle Strength
Description
Gastrocnemius Muscle Strength will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).
Time Frame
An average of 2 weeks (Phase I)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Electrical Stimulation for Critically Ill Covid-19 Patients
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