Clinical Application of the Effect of Respiratory Muscles Electrical Stimulation on Weaning in Patients With Difficult Weaning of the Mechanical Ventilation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Time to Successful Weaning (days)
Study Overview
Brief Summary
This trial evaluates whether transcutaneous diaphragmatic/phrenic nerve stimulation (TEDS), abdominal functional electrical stimulation (abFES), or their combination, accelerates and improves the quality of weaning from prolonged invasive mechanical ventilation (IMV), compared with standardized ICU care with sham stimulation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Invasive mechanical ventilation ≥21 days for PMV(at least 6 hours per day); expected ≥48 h Invasive mechanical ventilation.
- •Eligible for standardized weaning protocol and SBT assessment. Informed consent by participant or legally authorized representative.
Exclusion Criteria
- •Non-screenable/unstable arrhythmia or hemodynamics; refractory hypoxemia/hypercapnia.
- •Pacemaker/ICD not shieldable; seizure disorder uncontrolled. Recent abdominal surgery or skin breakdown at electrode sites; BMI>35; pregnancy.
- •Prone positioning; continuous deep neuromuscular blockade; investigator deems unsuitable.
Arms & Interventions
TEDS Only
TEDS + Sham abFES
Intervention: TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation) (Device)
TEDS Only
TEDS + Sham abFES
Intervention: Sham abFES (Device)
Combined
TEDS + abFES
Intervention: TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation) (Device)
Control
Sham TEDS + Sham abFES + Standard Care
Intervention: Sham TEDS (Device)
Control
Sham TEDS + Sham abFES + Standard Care
Intervention: Sham abFES (Device)
abFES Only
abFES + Sham TEDS
Intervention: abFES (Functional Electrical Stimulation of Abdominal Muscles) (Device)
abFES Only
abFES + Sham TEDS
Intervention: Sham TEDS (Device)
Combined
TEDS + abFES
Intervention: abFES (Functional Electrical Stimulation of Abdominal Muscles) (Device)
Outcomes
Primary Outcomes
Time to Successful Weaning (days)
Time Frame: From randomization up to Day 28
Days from randomization to first day achieving ≥48 h free from invasive mechanical ventilation (IMV).
Secondary Outcomes
- Ventilator-Free Days to Day 28 (VFDs-28)(Day 0-28 after randomization)
- Change in Diaphragm Thickening Fraction (TFdi) from Baseline to Day 28 (%)(Baseline to Day 28)
- Readmission(Readmission of 3 month/6 month/ 12 month)
- mortality(mortality of 3 month/6 month/ 12 month)
- Incidence of pulmonary infection(Incidence of pulmonary infection of 3 months/ 6 months/ 12 months)
- Change in Diaphragm Excursion (DE) Measured by M-mode Ultrasound from Baseline to Day 28 (cm)(Baseline (within 24 hours before randomization) and Day 28 after randomization)
- Change in Diaphragm Thickening Fraction (TFdi) from Baseline to Day 28 (%)(Baseline to Day 28)
- Change in Diaphragm Thickness (DT) Measured by B-mode Ultrasound from Baseline to Day 28 (mm)(Baseline to Day 28)
- Weaning Success From Invasive Mechanical Ventilation Within 28 Days (% of Participants)(Up to Day 28 after randomization)
- 28-Day In-hospital Cost From Randomization (CNY)(exactly 28 days)
- Change in PEF from Baseline to Day 28 (L/min)(Baseline to Day 28)
- Readmission(Readmission of 3 month/6 month/ 12 month)
- mortality(mortality of 3 month/6 month/ 12 month)
- Ventilator-Free Days to Day 28 (VFDs-28)(Day 0-28 after randomization)
Investigators
Yi Li
Principal Investigator
Capital Medical University