Electrical Stimulation in Patients With Prolonged Mechanical Ventilation

Study Overview
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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.

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.

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

Conditions
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Respiratory Failure

Intervention / Treatment
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* Other: electrical stimulation (high frequency)
* Other: electrical stimulation (low frequency)
* Other: sham group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Activity of Daily Life | 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 | 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 | 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 | The total days that participants stay in the respiratory care center (RCC). | the day participants were discharged from RCC | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prolong mechanical ventilator,, Electrical stimulation,, Activities of daily life,, Hospitalization outcomes.