Electric Muscle Stimulation for Patients With Chronic Respiratory Failure
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Electric Muscle Stimulation on Patients With Chronic Respiratory Failure|
- ventilator-free days [ Time Frame: 28 days ] [ Designated as safety issue: No ]the number of days between successful weaning from mechanical ventilation and day 28 after study enrollment
- Grip power [ Time Frame: 7 days ] [ Designated as safety issue: No ]Weekly improvement of both hand grip muscle power in kilogram(Kg)
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Electric muscle stimulation(EMS)
EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.
HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day.
No Intervention: Control
Patients with routine passive rehabilitation program.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01930643
|Contact: Kuang H Cheng, MDfirstname.lastname@example.org|
|Contact: Gwo C Hu, Phd|
|Mackay Memorial Hospital||Recruiting|
|Contact: Gwo C Hu +886-2-2543-3535|
|Principal Investigator:||Kuang H Cheng, MD||Mackay Memorial Hospital|