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

Capital Medical University

Status: Enrolling

Conditions: Mechanical Ventilation

Treatments: Device: Sham TEDS; Device: Sham abFES; Device: abFES (Functional Electrical Stimulation of Abdominal Muscles); Device: TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT07199036

2025bkky

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 4 patient groups

Control

Sham Comparator group

Description:

Sham TEDS + Sham abFES + Standard Care

Treatment:

Device: Sham abFES

Device: Sham TEDS

TEDS Only

Experimental group

Description:

TEDS + Sham abFES

Treatment:

Device: TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation)

Device: Sham abFES

abFES Only

Experimental group

Description:

abFES + Sham TEDS

Treatment:

Device: abFES (Functional Electrical Stimulation of Abdominal Muscles)

Device: Sham TEDS

Combined

Experimental group

Description:

TEDS + abFES

Treatment:

Device: abFES (Functional Electrical Stimulation of Abdominal Muscles)

Device: TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation)