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

NCT ID: NCT07199036

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-29

Study Completion Date

2026-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

Sham TEDS + Sham abFES + Standard Care

Group Type SHAM_COMPARATOR

Sham TEDS

Intervention Type DEVICE

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

Sham abFES

Intervention Type DEVICE

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

TEDS Only

TEDS + Sham abFES

Group Type EXPERIMENTAL

TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation)

Intervention Type DEVICE

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

Sham abFES

Intervention Type DEVICE

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

abFES Only

abFES + Sham TEDS

Group Type EXPERIMENTAL

abFES (Functional Electrical Stimulation of Abdominal Muscles)

Intervention Type DEVICE

Per session 20 min, twice daily

Sham TEDS

Intervention Type DEVICE

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

Combined

TEDS + abFES

Group Type EXPERIMENTAL

TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation)

Intervention Type 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)

Intervention Type DEVICE

Per session 20 min, twice daily

Interventions

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TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation)

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

Intervention Type DEVICE

abFES (Functional Electrical Stimulation of Abdominal Muscles)

Per session 20 min, twice daily

Intervention Type DEVICE

Sham TEDS

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

Intervention Type DEVICE

Sham abFES

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Invasive mechanical ventilation ≥21 days for PMV; expected ≥48 h ICU stay. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Rehabilitation Hospital

OTHER

Sponsor Role collaborator

Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yi Li

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Rehabilitation Hospital, Capital Medical University

Beijing, Shijingshan District, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Li Physiotherapy, Master

Role: CONTACT

86 13810913780

Facility Contacts

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Hongying Jiang

Role: primary

+86 13910579176

Other Identifiers

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2025bkky

Identifier Type: -

Identifier Source: org_study_id

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