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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Per session 20 min, twice daily; 5 days/week; up to 28 days or until successful weaning.
Per session 20 min, twice daily
Position/time matched; 2 Hz low-intensity sensation only; no visible contraction.
Beijing Rehabilitation Hospital, Capital Medical University
Beijing, Shijingshan District, China
RECRUITINGTime to Successful Weaning (days)
Days from randomization to first day achieving ≥48 h free from invasive mechanical ventilation (IMV).
Time frame: From randomization up to Day 28
Change in Diaphragm Excursion (DE) Measured by M-mode Ultrasound from Baseline to Day 28 (cm)
Diaphragm excursion will be measured by M-mode ultrasonography on the right hemidiaphragm. A 3.5-5.0 MHz convex probe is placed in the right subcostal region between the mid-clavicular and anterior axillary lines. The excursion (cm) during spontaneous breathe will be recorded as the average of three consecutive breaths. The outcome is the change in excursion from baseline to Day 28.
Time frame: Baseline (within 24 hours before randomization) and Day 28 after randomization
Change in Diaphragm Thickening Fraction (TFdi) from Baseline to Day 28 (%)
Diaphragm thickness will be measured in the zone of apposition of the right hemidiaphragm with a high-frequency linear probe in B-mode. Thickness at end-expiration and end-inspiration will be recorded as the average of three breaths. The diaphragm thickening fraction (TFdi, %) is calculated as: (Thickness at end-inspiration - Thickness at end-expiration) / Thickness at end-expiration × 100. The outcome is the change in TFdi from baseline to Day 28.
Time frame: Baseline to Day 28
Change in Diaphragm Thickness (DT) Measured by B-mode Ultrasound from Baseline to Day 28 (mm)
Diaphragm thickness (mm) will be measured in the zone of apposition of the right hemidiaphragm using a high-frequency linear probe (7-12 MHz) in B-mode at end-expiration. The value is the average of three consecutive breaths. The outcome is the change in diaphragm thickness from baseline to Day 28.
Time frame: Baseline to Day 28
Weaning Success From Invasive Mechanical Ventilation Within 28 Days (% of Participants)
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Position/time matched; sensation only; no visible contraction.
Weaning success is defined as remaining free from invasive mechanical ventilation for at least 48 hours after extubation or tracheostomy decannulation. The outcome is the proportion of randomized participants who achieve successful weaning within 28 days after randomization.
Time frame: Up to Day 28 after randomization
28-Day In-hospital Cost From Randomization (CNY)
Total in-hospital cost (Chinese Yuan) during the first 28 days after randomization
Time frame: exactly 28 days
Change in PEF from Baseline to Day 28 (L/min)
Time frame: Baseline to Day 28
Readmission
Time frame: Readmission of 3 month/6 month/ 12 month
mortality
Time frame: mortality of 3 month/6 month/ 12 month
Incidence of pulmonary infection
Time frame: Incidence of pulmonary infection of 3 months/ 6 months/ 12 months
Ventilator-Free Days to Day 28 (VFDs-28)
Time frame: Day 0-28 after randomization