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Transcutaneous Electrical Diaphragmatic Stimulation in PMV Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04281810
Enrollment
59
Registered
2020-02-24
Start date
2017-04-20
Completion date
2019-07-25
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation

Keywords

electrical stimulation, diaphragmatic, weaning, respiratory muscle

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.

Interventions

DEVICEtranscutaneous electric diaphragm stimulation

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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Subjects were not informed of the results of allocation

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
respiratory muscle strength (maximal inspiratory pressure)the 1st day of interventionpressure gauge
tidal volume1st day of interventionThe tidal volume was measured by a spirometer
rapid shallow breathing index1st day of interventionrespiratory rate/tidal volume
respiratory muscle strength (maximal expiratory pressure)the 1st day of interventionpressure gauge

Secondary

MeasureTime frameDescription
weaning ratethrough study completion,an average of 7 weeksventilator weaning results (weaning successful/failure)
length of stay in respiratory care centerthrough study completion,an average of 7 weeksthe total days of stay in respiratory care center

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026