An interventional study of transcutaneous electric diaphragm stimulation in Mechanical Ventilation, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-02-24.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Other
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.
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.
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Exclusion Criteria:
Subjects received transcutaneous electrical diaphragm stimulation (TEDS) for 30min/ day till the end of the weaning trial
Device: transcutaneous electric diaphragm stimulation
Subjects received similar medical treatment except for the TEDS program.
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.
tidal volume
The tidal volume was measured by a spirometer
Time frame: 1st day of intervention
tidal volume
The tidal volume was measured by a spirometer
Time frame: through study completion,an average of 4 weeks
rapid shallow breathing index
respiratory rate/tidal volume
Time frame: 1st day of intervention
rapid shallow breathing index
respiratory rate/tidal volume
Time frame: through study completion,an average of 4 weeks
respiratory muscle strength (maximal inspiratory pressure)
pressure gauge
Time frame: the 1st day of intervention
respiratory muscle strength (maximal expiratory pressure)
pressure gauge
Time frame: the 1st day of intervention
respiratory muscle strength (maximal inspiratory pressure)
pressure gauge
Time frame: through study completion,an average of 4 weeks
respiratory muscle strength (maximal expiratory pressure)
pressure gauge
Time frame: through study completion,an average of 4 weeks
weaning rate
ventilator weaning results (weaning successful/failure)
Time frame: through study completion,an average of 7 weeks
length of stay in respiratory care center
the total days of stay in respiratory care center
Time frame: through study completion,an average of 7 weeks
Plan to share: No
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital