Clinical trial NCT02227810: Electrical Stimulation in Patients With Prolonged Mechanical Ventilation
Official title: Effects of Muscular Electrical Stimulation on Skeletal and Lung Mechanics in Patients With Prolonged Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: Prolong mechanical ventilator,
Electrical stimulation,
Activities of daily life,
Hospitalization outcomes.
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of Activity of Daily Life
timeFrame: end of intervention
measure: Muscle Strength
timeFrame: end of intervention
measure: Pulmonary Function
timeFrame: end of intervention
Secondary outcomes:
measure: Hospitalization Outcomes
timeFrame: the day participants were discharged from RCC
Other outcomes:
Locations:
city: Tao-Yuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
affiliation: Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital,Linkou, Taiwan
name: Chung-Chi Huang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen YH, Hsiao HF, Li LF, Chen NH, Huang CC. Effects of Electrical Muscle Stimulation in Subjects Undergoing Prolonged Mechanical Ventilation. Respir Care. 2019 Mar;64(3):262-271. doi: 10.4187/respcare.05921. Epub 2019 Feb 5.