Electrical Stimulation in Patients With Prolonged Mechanical Ventilation
- Conditions
- Respiratory Failure
- Interventions
- Other: sham groupOther: electrical stimulation (high frequency)Other: electrical stimulation (low frequency)
- Registration Number
- NCT02227810
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- 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);
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sham group sham group Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off. electrical stimulation electrical stimulation (low frequency) Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days electrical stimulation electrical stimulation (high frequency) Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
- Primary Outcome Measures
Name Time Method Pulmonary Function end of intervention The pulmonary function as assessed by the measurement of tidal volume.
Level of Activity of Daily Life 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).
Muscle Strength 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.
- Secondary Outcome Measures
Name Time Method Hospitalization Outcomes the day participants were discharged from RCC The total days that participants stay in the respiratory care center (RCC).
Trial Locations
- Locations (1)
Chang Gung Memorial Hospital, Linkou
🇨🇳Tao-Yuan, Taiwan