Electric Muscle Stimulation for Patients With Chronic Respiratory Failure

Chronic Respiratory Failure Clinical Trial

Official title:

Effect of Electric Muscle Stimulation on Patients With Chronic Respiratory Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01930643
• Other study ID #: 13MMHIS070
• Status: Terminated
• Phase: N/A
• Start date: August 21, 2013
• Est. completion date: June 2015

Study information

• Verified date: April 2019
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Respiratory Failure
• Critical Illness
• Critical Illness Myopathy
• Respiratory Insufficiency

Intervention

Device:
• EMS
HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day.

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-free Days	the cumulative ventilator-free days after intervention, in following 28 days.	28 days
Secondary	Grip Power	Weekly improvement of both hand grip muscle power in kilogram(Kg)	7 days after intervention