Transcutaneous Electrical Diaphragmatic Stimulation in PMV Patients

Not Applicable

Completed

• Conditions: Mechanical Ventilation
• Interventions: Device: transcutaneous electric diaphragm stimulation

• Registration Number: NCT04281810
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Muscle atrophy and diaphragm dysfunction are common with prolonged mechanical ventilation (PMV). Electrical stimulation has been shown to be beneficial in severe chronic heart failure and chronic obstructive pulmonary disease. However, its effect on PMV is unclear. This study examined the effects of transcutaneous electrical diaphragmatic stimulation (TEDS) on respiratory muscle strength and weaning outcomes in patients with PMV.

Detailed Description

Patients on ventilation for ≥21 days were randomly assigned to TEDS and control groups. The TEDS group received muscle electrical stimulation for 30 min/session/day throughout the intervention. Weaning parameters (tidal volume, respiratory rate, and rapid shallow breathing index) and respiratory muscle strength (Pimax, Pemax) were assessed. The hospitalization outcome, including weaning rate and length of stay, was followed up until discharge.

Study Timeline

• Study Start: 2017-04-20
• Primary Completion: 2018-09-29
• Study Completion: 2019-07-25
• Status Verified: 2020-02
• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-21
• Last Update Submitted: 2020-02-21
• Study First Posted: 2020-02-24
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Age ≥ 20 years;
• MV for > 6 h/day for > 21 days;
• Medical stability (PaO2 ≥ 60 mmHg at 40% FiO2, absence of signs and symptoms of infection, and hemodynamic stability).

Exclusion Criteria

• Acute lung or systemic infection, hemodynamic instability, patients with pacemakers, abdominal distention, and pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEDS	transcutaneous electric diaphragm stimulation	Subjects received transcutaneous electrical diaphragm stimulation (TEDS) for 30min/ day till the end of the weaning trial

Primary Outcome Measures

Name	Time	Method
respiratory muscle strength (maximal expiratory pressure)	through study completion,an average of 4 weeks	pressure gauge
rapid shallow breathing index	through study completion,an average of 4 weeks	respiratory rate/tidal volume
tidal volume	through study completion,an average of 4 weeks	The tidal volume was measured by a spirometer
respiratory muscle strength (maximal inspiratory pressure)	through study completion,an average of 4 weeks	pressure gauge

Secondary Outcome Measures

Name	Time	Method
weaning rate	through study completion,an average of 7 weeks	ventilator weaning results (weaning successful/failure)
length of stay in respiratory care center	through study completion,an average of 7 weeks	the total days of stay in respiratory care center

Trial Locations

Locations (1)

Chang Gung University; 🇨🇳 TaoYuan City, Tao-Yuan, Taiwan