Mechanical Ventilation
Conditions
Keywords
Prolonged Mechanical Ventilation, transcutaneous phrenic nerve electrical stimulation, abdominal functional electrical stimulation
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.
Interventions
DEVICETEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation)
Per session 20 min, twice daily; 5 days/week; up to 28 days or until successful weaning.
DEVICEabFES (Functional Electrical Stimulation of Abdominal Muscles)
Per session 20 min, twice daily
DEVICESham TEDS
Position/time matched; 2 Hz low-intensity sensation only; no visible contraction.
DEVICESham abFES
Position/time matched; sensation only; no visible contraction.
Sponsors
Capital Medical University
Beijing Rehabilitation Hospital of Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Successful Weaning (days) | From randomization up to Day 28 | Days from randomization to first day achieving ≥48 h free from invasive mechanical ventilation (IMV). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Change in Diaphragm Thickening Fraction (TFdi) from Baseline to Day 28 (%) | 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. |
| Change in Diaphragm Thickness (DT) Measured by B-mode Ultrasound from Baseline to Day 28 (mm) | Baseline to Day 28 | 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. |
| Weaning Success From Invasive Mechanical Ventilation Within 28 Days (% of Participants) | Up to Day 28 after randomization | 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. |
| 28-Day In-hospital Cost From Randomization (CNY) | exactly 28 days | Total in-hospital cost (Chinese Yuan) during the first 28 days after randomization |
| Change in PEF from Baseline to Day 28 (L/min) | Baseline to Day 28 | — |
| Readmission | Readmission of 3 month/6 month/ 12 month | The original protocol planned to follow up patients at 3, 6, and 12 months post-discharge for readmission. Due to a low follow-up response rate (patients lost to follow-up, transferred elsewhere, or with incomplete contact information), the available data were insufficient for reliable analysis. This outcome was therefore removed, and the study instead focuses on in-hospital clinical outcomes. |
| mortality | mortality of 3 month/6 month/ 12 month | The original protocol planned to follow up patients at 3, 6, and 12 months post-discharge for mortality. Due to a low follow-up response rate (patients lost to follow-up, transferred elsewhere, or with incomplete contact information), the available data were insufficient for reliable analysis. This outcome was therefore removed, and the study instead focuses on in-hospital clinical outcomes. |
| Incidence of pulmonary infection | Incidence of pulmonary infection of 3 months/ 6 months/ 12 months | The original protocol planned to follow up patients at 3, 6, and 12 months post-discharge for pulmonary infection. Due to a low follow-up response rate (patients lost to follow-up, transferred elsewhere, or with incomplete contact information), the available data were insufficient for reliable analysis. This outcome was therefore removed, and the study instead focuses on in-hospital clinical outcomes. |
| Ventilator-Free Days to Day 28 (VFDs-28) | Day 0-28 after randomization | — |
Countries
China
Outcome results
None listed