NCT07199036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 29, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2026

Completed
Last Updated

March 10, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

September 29, 2025

Last Update Submit

March 9, 2026

Conditions

Mechanical Ventilation

Keywords

Prolonged Mechanical Ventilationtranscutaneous phrenic nerve electrical stimulationabdominal functional electrical stimulation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (10)

  • 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

  • Change in Diaphragm Thickening Fraction (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)

    Baseline to Day 28

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

    Up to Day 28 after randomization

  • 28-Day In-hospital Cost From Randomization (CNY)

    exactly 28 days

  • +5 more secondary outcomes

Study Arms (4)

Control

SHAM COMPARATOR

Sham TEDS + Sham abFES + Standard Care

Device: Sham TEDSDevice: Sham abFES

TEDS Only

EXPERIMENTAL

TEDS + Sham abFES

Device: TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation)Device: Sham abFES

abFES Only

EXPERIMENTAL

abFES + Sham TEDS

Device: abFES (Functional Electrical Stimulation of Abdominal Muscles)Device: Sham TEDS

Combined

EXPERIMENTAL

TEDS + abFES

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

Interventions

TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation)DEVICE

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

CombinedTEDS Only
Sham TEDSDEVICE

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

ControlabFES Only
Sham abFESDEVICE

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

ControlTEDS Only
abFES (Functional Electrical Stimulation of Abdominal Muscles)DEVICE

Per session 20 min, twice daily

CombinedabFES Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Rehabilitation Hospital, Capital Medical University

Beijing, Shijingshan District, 100144, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2025

First Posted

September 30, 2025

Study Start

September 29, 2025

Primary Completion

March 1, 2026

Study Completion

March 8, 2026

Last Updated

March 10, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)