- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04281810
Transcutaneous Electrical Diaphragmatic Stimulation in PMV Patients
February 21, 2020 updated by: Chang Gung Memorial Hospital
Effects of Transcutaneous Electrical Diaphragmatic Stimulation on Respiratory Function in Patients With Prolonged Mechanical Ventilation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tao-Yuan
-
TaoYuan City, Tao-Yuan, Taiwan, 333
- Chang Gung University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TEDS
Subjects received transcutaneous electrical diaphragm stimulation (TEDS) for 30min/ day till the end of the weaning trial
|
The electrodes were placed on the parasternal region beside the xiphoid process; and the sixth and seventh intercostal spaces in line with the mid-axillary line.
TEDS was set as biphasic waves, frequency of 30 Hz, pulse width of 400 μs, and rise time of 0.7s.
|
No Intervention: Control
Subjects received similar medical treatment except for the TEDS program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tidal volume
Time Frame: 1st day of intervention
|
The tidal volume was measured by a spirometer
|
1st day of intervention
|
tidal volume
Time Frame: through study completion,an average of 4 weeks
|
The tidal volume was measured by a spirometer
|
through study completion,an average of 4 weeks
|
rapid shallow breathing index
Time Frame: 1st day of intervention
|
respiratory rate/tidal volume
|
1st day of intervention
|
rapid shallow breathing index
Time Frame: through study completion,an average of 4 weeks
|
respiratory rate/tidal volume
|
through study completion,an average of 4 weeks
|
respiratory muscle strength (maximal inspiratory pressure)
Time Frame: the 1st day of intervention
|
pressure gauge
|
the 1st day of intervention
|
respiratory muscle strength (maximal expiratory pressure)
Time Frame: the 1st day of intervention
|
pressure gauge
|
the 1st day of intervention
|
respiratory muscle strength (maximal inspiratory pressure)
Time Frame: through study completion,an average of 4 weeks
|
pressure gauge
|
through study completion,an average of 4 weeks
|
respiratory muscle strength (maximal expiratory pressure)
Time Frame: through study completion,an average of 4 weeks
|
pressure gauge
|
through study completion,an average of 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
weaning rate
Time Frame: through study completion,an average of 7 weeks
|
ventilator weaning results (weaning successful/failure)
|
through study completion,an average of 7 weeks
|
length of stay in respiratory care center
Time Frame: through study completion,an average of 7 weeks
|
the total days of stay in respiratory care center
|
through study completion,an average of 7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yi-Fei Hsin, Chang Gung Memorial Hospital
- Study Director: Yen-Huey Chen, Chang Gung University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2017
Primary Completion (Actual)
September 29, 2018
Study Completion (Actual)
July 25, 2019
Study Registration Dates
First Submitted
February 18, 2020
First Submitted That Met QC Criteria
February 21, 2020
First Posted (Actual)
February 24, 2020
Study Record Updates
Last Update Posted (Actual)
February 24, 2020
Last Update Submitted That Met QC Criteria
February 21, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 201700096A3D001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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