N/A N=53 Randomized Single-blind Treatment

Electrical Stimulation in Patients With Prolonged Mechanical Ventilation

Respiratory Failure

Bottom Line

View on ClinicalTrials.gov: NCT02227810 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Mar 2017

Primary outcome: Primary: Level of Activity of Daily Life — 25.2; 32.0 units on a scale — p=0.652

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: electrical stimulation (high frequency) (Other); electrical stimulation (low frequency) (Other); sham group (Other)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Chang Gung Memorial Hospital
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Level of Activity of Daily Life	25.2; 32.0	0.652
PRIMARY Muscle Strength	1.7; 2.7	0.051
PRIMARY Pulmonary Function	164.7; 214.4	0.051
SECONDARY Hospitalization Outcomes	34.2; 32.3	0.792

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.

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 35kg/m2

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Data sourced from ClinicalTrials.gov (NCT02227810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.