Electrical Stimulation in Patients With Prolonged Mechanical Ventilation

Chang Gung Medical Foundation

Status: Completed

Conditions: Respiratory Failure

Treatments: Other: sham group; Other: electrical stimulation (high frequency); Other: electrical stimulation (low frequency)

Study type: Interventional

Funder types: Other

Identifiers

NCT02227810

103-1702C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

electrical stimulation

Experimental group

Description:

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

Treatment:

Other: electrical stimulation (high frequency)

Other: electrical stimulation (low frequency)

sham group

Sham Comparator group

Description:

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

Treatment:

Other: sham group