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Clinical Trials/NCT04281810
NCT04281810
Completed
Not Applicable

Effects of Transcutaneous Electrical Diaphragmatic Stimulation on Respiratory Function in Patients With Prolonged Mechanical Ventilation

Chang Gung Memorial Hospital1 site in 1 country59 target enrollmentApril 20, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mechanical Ventilation
Sponsor
Chang Gung Memorial Hospital
Enrollment
59
Locations
1
Primary Endpoint
rapid shallow breathing index
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2017
End Date
July 25, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

rapid shallow breathing index

Time Frame: through study completion,an average of 4 weeks

respiratory rate/tidal volume

tidal volume

Time Frame: through study completion,an average of 4 weeks

The tidal volume was measured by a spirometer

respiratory muscle strength (maximal inspiratory pressure)

Time Frame: through study completion,an average of 4 weeks

pressure gauge

respiratory muscle strength (maximal expiratory pressure)

Time Frame: through study completion,an average of 4 weeks

pressure gauge

Secondary Outcomes

  • weaning rate(through study completion,an average of 7 weeks)
  • length of stay in respiratory care center(through study completion,an average of 7 weeks)

Study Sites (1)

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