Electrical Stimulation in Patients With Prolonged Mechanical Ventilation

February 7, 2017 updated by: Chang Gung Memorial Hospital

Effects of Muscular Electrical Stimulation on Skeletal and Lung Mechanics in Patients With Prolonged Mechanical Ventilation

Muscle atrophy and diaphragm dysfunction are common complication in patients with prolong mechanical ventilator (PMV) and is associated with increased rate of weaning failure and days of hospitalization. Electrical stimulation (ES) has been shown to be beneficial in patients with severe chronic heart failure and chronic obstructive pulmonary disease. The purpose of this study is to examine the effects of ES on skeletal muscle function, pulmonary mechanics and hospitalization outcomes in patients with PMV.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND AND PURPOSE: Muscle atrophy and diaphragm dysfunction are common complication in patients with prolong mechanical ventilator (PMV) and is associated with increased rate of weaning failure and days of hospitalization. Electrical stimulation (ES) has been shown to be beneficial in patients with severe chronic heart failure and chronic obstructive pulmonary disease. The purpose of this study is to examine the effects of ES on skeletal muscle function, pulmonary mechanics and hospitalization outcomes in patients with PMV.

METHODS: Patients who have been on mechanical ventilator for more than 21 days will be recruited from respiratory care center (RCC). All subjects will be randomly assigned into three groups: ES in abdominal muscles (ES-Abd, n=30),ES in brachial biceps (ES-bicep, n=30) and sham group(Sham). Subjects in both groups will receive ES in muscles for 30 min/session, 2 sessions/day for 10 days with the same setting except area of ES. The muscle function will be assessed by skin-fold thickness and muscle strength. The pulmonary function will be assessed by: lung compliance, airway resistance, tidal volume, minute volume and maximal inspiratory pressure. The hospitalization outcome will be followed up until patients are discharged from RCC. The outcomes variables include: weaning rate and duration, mortality, days of ventilator, and length of RCC stay.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tao-Yuan, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age>20 years old
  • mechanical ventilation for more than 6 h/ day for more than 21 days -- medical stability (arterial blood gas value hydrogen power(pH): 7.35-7.45, atrial oxygen pressure(PaO2): 60 mmHg at 40% fraction of inspired oxygen inspired oxygen fraction (FiO2), absence of signs and symptoms of infection, and hemodynamic stability);

Exclusion Criteria:

  • signs of acute infection (BT>38.5℃，WBC>12000 or <3000 per unit
  • neuromuscular disease at acute stage
  • diagnosis of cancer at end-stage
  • pregnancy
  • BMI>35kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: electrical stimulation
Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
Other: electrical stimulation (high frequency)
Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days
Other: electrical stimulation (low frequency)
Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.
Sham Comparator: sham group
Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
Other: sham group
Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Activity of Daily Life
Time Frame: end of intervention
The level of activity of daily life was measured by Functional Independence Measure (FIM) score. Possible scores range from 18 (total assist) to 126 (complete independence).
end of intervention
Muscle Strength
Time Frame: end of intervention
The muscle strength of quadriceps were assessed by Medical Research Council (MRC) scoring system. The MRC score ranges from a 0 points (zero strength) to 5 points (good). The higher points indicated the better muscle strength.
end of intervention
Pulmonary Function
Time Frame: end of intervention
The pulmonary function as assessed by the measurement of tidal volume.
end of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization Outcomes
Time Frame: the day participants were discharged from RCC
The total days that participants stay in the respiratory care center (RCC).
the day participants were discharged from RCC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chung-Chi Huang, Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital,Linkou, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 28, 2014

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103-1702C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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