Critical Illness Clinical Trial
Official title:
Effect of Treatment With the Niveus Medical Muscle Stimulation System 110 on Quadriceps Strength In Mechanically Ventilated Patients
Verified date | June 2020 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients who are admitted to the intensive care unit and require mechanical ventilation frequently develop profound respiratory and limb muscle weakness. Studies show that the development of weakness during the ICU stay results in poor outcomes. Currently there are no treatments for this muscle weakness, but it has been suggested that this weakness might improve with physical therapy. Electrical stimulation is a method to provide direct stimulation to the muscles potentially enhancing function and improving strength. The purpose of this study is to test the hypothesis that neuromuscular electrical stimulation of the quadriceps muscle will improve muscle strength in patients who are critically ill on mechanical ventilation.
Status | Terminated |
Enrollment | 2 |
Est. completion date | February 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Acute respiratory failure requiring mechanical ventilation Exclusion Criteria: - Attending physician on service determines that patient too unstable to tolerate measurements - Patient requires > 15mcg/min norepinephrine or > 15mg/kg/min of dopamine. - Fraction of inspired oxygen > 80% or positive end expiratory pressure > 15 cm H20 requirements. - Cardiac pacemaker or implanted defibrillator. - Neuromuscular blocking agents delivered within 48 hours of preceding testing. - Existing neuromuscular disease. - Profound uncorrectable hypokalemia (< 2.5) OR hypophosphatemia (< 1.0) - Acute lower extremity deep vein thrombosis - Pregnancy - Prisoner - Institutionalized patient - If primary attending determines that patient is terminal and will likely have care withdrawn within 7 days - Do not resuscitate order - Body mass index > 40 - Patients requiring mechanical ventilation more than 4 days prior to study entry |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky Medical Center | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Gerald Supinski |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rectus Femorus thickness | Rectus femorus thickness will be measured using ultrasound at baseline (study entry) and on Day 8 of study after either sham treatment or neuromuscular stimulation | Day 8 | |
Primary | Technical Feasibility, that is ability to complete therapy sessions | Percentage of patients who completed treatment with the device | Discharge from ICU, Average 7-10 days | |
Secondary | Total ICU length of stay | Average 7-10 days | Discharge from ICU, Average 7-10 days | |
Secondary | Hospital Length of Stay | Average 14-21 days | Hospital discharge, Average 14-21 days | |
Secondary | Functional Status Score for ICU | Average 7-10 days after study entry | ICU discharge, Average 7-10 days after study entry | |
Secondary | Duration of mechanical ventilation after study entry | Average 4-10 days | Until patient is successfully weaned from mechanical ventilation, Average 4-10 days | |
Secondary | Change in quadriceps twitch force generation | Quadriceps twitch force generation will be measured using magnetic stimulation of each femoral nerve and compared to measurements obtained at the time of study entry (baseline-prior to randomization) | Baseline (prior to Treatment) and Day 8 |
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