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Transcutaneous Electrical Diaphragmatic Stimulation in PMV Patients

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Mechanical Ventilation

Treatments

Device: transcutaneous electric diaphragm stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04281810
201700096A3D001

Details and patient eligibility

About

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.

Full 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.

Enrollment

59 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

59 participants in 2 patient groups

TEDS
Experimental group
Description:
Subjects received transcutaneous electrical diaphragm stimulation (TEDS) for 30min/ day till the end of the weaning trial
Treatment:
Device: transcutaneous electric diaphragm stimulation
Control
No Intervention group
Description:
Subjects received similar medical treatment except for the TEDS program.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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