CTRI/2026/02/103718Not yet recruitingNot Applicable
Functional electrical stimulation of abdominal musculature in patients on mechanical ventilation following chest trauma: A pilot feasibility open randomized controlled trial
Kapil Dev Soni1 site in 1 country60 target enrollmentStarted: March 2, 2026Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
Study Overview
Brief Summary
Functional electrical stimulation (FES) of abdominal musculature in mechanically ventilated patients following chest trauma will be evaluated in a pilot, feasibility, open randomized controlled trial to determine whether this intervention could improve respiratory outcomes and assist ventilator weaning. Patients with chest trauma requiring mechanical ventilation will be randomized to receive either standard care alone or standard care plus FES applied to abdominal muscles. The feasibility outcomes included recruitment rate, protocol adherence, safety, and patient tolerance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •age more than 18 years or equal to 18 years.
- •patients having chest injury.
- •patients must be dependent on mechanical ventilation due to critical illness.
Exclusion Criteria
- •Patients will be excluded if they are expected to be ventilated for less than 24 h or already ventilated for more than 72 h pregnant neurological paralysis (e.g. spinal cord injury) physical obstacles that prevent abdominal FES (e.g. abdominal trauma) A diagnosed terminal illness Known morbidly obese.
- •abdominal surgery within 4 weeks prior to potential inclusion.
- •Uncooperative patient.
- •Patients with pacemakers, NMR-Imaging, defibrillators.
- •Patients with autonomic dysreflexia.
Investigators
KAPIL DEV SONI
All India Institute of Medical Sciences, New Delhi
Study Sites (1)
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