Electric Muscle Stimulation for Patients With Chronic Respiratory Failure

Not Applicable

Terminated

• Conditions: Critical Illness Myopathy; Chronic Respiratory Failure
• Interventions: Device: EMS

• Registration Number: NCT01930643
• Lead Sponsor: Mackay Memorial Hospital

Brief Summary

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

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).

Study Timeline

• Study Start: 2013-08-21
• Study First Submitted: 2013-08-25
• Study First Submitted QC: 2013-08-25
• Study First Posted: 2013-08-29
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2019-04
• Results First Submitted: 2019-04-18
• Results First Submitted QC: 2019-04-18
• Last Update Submitted: 2019-04-18
• Results First Posted: 2019-07-08
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electric muscle stimulation(EMS)	EMS	EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.

Primary Outcome Measures

Name	Time	Method
Ventilator-free Days	28 days	the cumulative ventilator-free days after intervention, in following 28 days.

Secondary Outcome Measures

Name	Time	Method
Grip Power	7 days after intervention	Weekly improvement of both hand grip muscle power in kilogram(Kg)

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan