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Electric Muscle Stimulation for Patients With Chronic Respiratory Failure

This study has suspended participant recruitment.
(slow recruitment and change of faculty)
Sponsor:
Information provided by (Responsible Party):
Kuang-Hua Cheng, MD, Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01930643
First received: August 25, 2013
Last updated: November 4, 2016
Last verified: November 2016
  Purpose

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.


Condition Intervention
Chronic Respiratory Failure
Critical Illness Myopathy
Device: EMS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Electric Muscle Stimulation on Patients With Chronic Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Kuang-Hua Cheng, MD, Mackay Memorial Hospital:

Primary Outcome Measures:
  • ventilator-free days [ Time Frame: 28 days ]
    the number of days between successful weaning from mechanical ventilation and day 28 after study enrollment


Secondary Outcome Measures:
  • Grip power [ Time Frame: 7 days ]
    Weekly improvement of both hand grip muscle power in kilogram(Kg)


Estimated Enrollment: 100
Study Start Date: August 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: Control
Patients with routine passive rehabilitation program.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930643

Locations
Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Principal Investigator: Kuang H Cheng, MD Mackay Memorial Hospital
  More Information

Responsible Party: Kuang-Hua Cheng, MD, Visiting staff, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT01930643     History of Changes
Other Study ID Numbers: 13MMHIS070
Study First Received: August 25, 2013
Last Updated: November 4, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Kuang-Hua Cheng, MD, Mackay Memorial Hospital:
Electric muscle stimulation
mechanical ventilation
chronic respiratory failure

Additional relevant MeSH terms:
Respiratory Insufficiency
Critical Illness
Respiration Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 25, 2017