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NCT Number: NCT07199036

Clinical Application of the Effect of Respiratory Muscles Electrical Stimulation on Weaning in Patients With Difficult Weaning of the Mechanical Ventilation

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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Key information

Conditions

Mechanical Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Rehabilitation Hospital, Capital Medical University

Beijing, Shijingshan District, 100144, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation)

Device

Per session 20 min, twice daily; 5 days/week; up to 28 days or until successful weaning.

abFES (Functional Electrical Stimulation of Abdominal Muscles)

Device

Per session 20 min, twice daily

Sham TEDS

Device

Position/time matched; 2 Hz low-intensity sensation only; no visible contraction.

Sham abFES

Device

Position/time matched; sensation only; no visible contraction.

Primary outcomes

  1. 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

  1. Change in Diaphragm Excursion (DE) Measured by M-mode Ultrasound from Baseline to Day 28 (cm)

    Time frame: 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.

  2. Change in Diaphragm Thickening Fraction (TFdi) from Baseline to Day 28 (%)

    Time frame: 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.

  3. Change in Diaphragm Thickness (DT) Measured by B-mode Ultrasound from Baseline to Day 28 (mm)

    Time frame: 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.

  4. Weaning Success From Invasive Mechanical Ventilation Within 28 Days (% of Participants)

    Time frame: 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.

  5. 28-Day In-hospital Cost From Randomization (CNY)

    Time frame: exactly 28 days

    Total in-hospital cost (Chinese Yuan) during the first 28 days after randomization

  6. Change in PEF from Baseline to Day 28 (L/min)

    Time frame: Baseline to Day 28

  7. Readmission

    Time frame: Readmission of 3 month/6 month/ 12 month

  8. mortality

    Time frame: mortality of 3 month/6 month/ 12 month

  9. Incidence of pulmonary infection

    Time frame: Incidence of pulmonary infection of 3 months/ 6 months/ 12 months

  10. Ventilator-Free Days to Day 28 (VFDs-28)

    Time frame: Day 0-28 after randomization

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

  • Beijing Rehabilitation Hospital of Capital Medical University

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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