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| Name | Class |
|---|---|
| Beijing Rehabilitation Hospital of Capital Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | Sham TEDS + Sham abFES + Standard Care |
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| TEDS Only | Experimental | TEDS + Sham abFES |
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| abFES Only | Experimental | abFES + Sham TEDS |
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| Combined | Experimental | TEDS + abFES |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation) | Device | Per session 20 min, twice daily; 5 days/week; up to 28 days or until successful weaning. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Successful Weaning (days) | Days from randomization to first day achieving ≥48 h free from invasive mechanical ventilation (IMV). | From randomization up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Eligible for standardized weaning protocol and SBT assessment. Informed consent by participant or legally authorized representative.
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Rehabilitation Hospital, Capital Medical University | Beijing | Shijingshan District | 100144 | China |
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| abFES (Functional Electrical Stimulation of Abdominal Muscles) | Device | Per session 20 min, twice daily |
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| Sham TEDS | Device | Position/time matched; 2 Hz low-intensity sensation only; no visible contraction. |
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| Sham abFES | Device | Position/time matched; sensation only; no visible contraction. |
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| 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. | 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. | Baseline to Day 28 |
| Weaning Success From Invasive Mechanical Ventilation Within 28 Days (% of Participants) | 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. | 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 | 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 |
| Incidence of pulmonary infection | Incidence of pulmonary infection of 3 months/ 6 months/ 12 months |
| Ventilator-Free Days to Day 28 (VFDs-28) | Day 0-28 after randomization |