Electrical Stimulation in Patients With Prolonged Mechanical Ventilation

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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electrical stimulation

Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days

Group Type EXPERIMENTAL

electrical stimulation (high frequency)

Intervention Type OTHER

Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days

electrical stimulation (low frequency)

Intervention Type OTHER

Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.

sham group

Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.

Group Type SHAM_COMPARATOR

sham group

Intervention Type OTHER

Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.

Interventions

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electrical stimulation (high frequency)

Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days

Intervention Type OTHER

electrical stimulation (low frequency)

Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.

Intervention Type OTHER

sham group

Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No