Electric Muscle Stimulation for Patients With Chronic Respiratory Failure

Study Overview
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Brief Summary
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Background: After mechanical ventilation, 5-20% of patients with acute respiratory failure would depend on ventilator support more than 14 days because of critical-illness weakness and their underlying diseases such as heart failure and chronic obstructive pulmonary disease. Hypothesis: Electric muscle stimulation(EMS) will improve their muscle strength and shorten their ventilator days. Design: Randomized controlled trial. Adult patients with mechanical ventilation more than 14 days are eligible. EMS would be applied in experimental group 32 minutes/day on their bilateral thigh.

Detailed Description
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Randomized controlled trial involves the adult patients with invasive mechanical ventilation more than 14 days. The participants were not eligible for active rehabilitation because of drowisness or weakness(Medical Research Council (MRC) Scale for Muscle Strength≦ Grade 3). EMS would be applied in experimental group 32 minutes/day on their bilateral thigh(quadriceps muscle).

Official Title
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Effect of Electric Muscle Stimulation on Patients With Chronic Respiratory Failure

Conditions
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Chronic Respiratory Failure, Critical Illness Myopathy

Intervention / Treatment
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* Device: EMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient required mechanical ventilation more than 14 days No ability for active endurance exercise because of poor consciousness or limb weakness. Exclusion Criteria: Pregnant women Limb wound/infection interfered with electric pad application Recent acute myocardial infarction or life-threatening arrhythmia Uncontrolled epilepsy Dying patients without attempt of ventilator weaning Absence of respiratory drive

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electric muscle stimulation(EMS)<br>EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week. | Device: EMS<br>* HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day.<br>|
| No Intervention: Control<br>Patients with routine passive rehabilitation program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-free Days | the cumulative ventilator-free days after intervention, in following 28 days. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip Power | Weekly improvement of both hand grip muscle power in kilogram(Kg) | 7 days after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electric muscle stimulation, mechanical ventilation, chronic respiratory failure