Mechanical VentilationNCT07199036
Clinical Application of the Effect of Respiratory Muscles Electrical Stimulation on Weaning in Patients With Difficult Weaning of the Mechanical Ventilation
A study testing TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation) and abFES (Functional Electrical Stimulation of Abdominal Muscles) in people with Mechanical Ventilation, run by Capital Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation) and abFES (Functional Electrical Stimulation of Abdominal Muscles)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Beijing Rehabilitation Hospital, Capital Medical University
Beijing, Shijingshan District, 100144
About this study
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.
- Conditions
- Mechanical Ventilation
- Being tested
- TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation), abFES (Functional Electrical Stimulation of Abdominal Muscles), Sham TEDS, Sham abFES
- Keywords
- Prolonged Mechanical Ventilation, transcutaneous phrenic nerve electrical stimulation, abdominal functional electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 TEDSDevice
Position/time matched; 2 Hz low-intensity sensation only; no visible contraction.
Sham abFESDevice
Position/time matched; sensation only; no visible contraction.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Sham TEDS + Sham abFES + Standard Care Receives: Device: Sham TEDS; Device: Sham abFES |
| TEDS Only | Experimental | TEDS + Sham abFES Receives: Device: TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation); Device: Sham abFES |
| abFES Only | Experimental | abFES + Sham TEDS Receives: Device: abFES (Functional Electrical Stimulation of Abdominal Muscles); Device: Sham TEDS |
| Combined | Experimental | TEDS + abFES Receives: Device: TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation); Device: abFES (Functional Electrical Stimulation of Abdominal Muscles) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Successful Weaning (days)
Days from randomization to first day achieving ≥48 h free from invasive mechanical ventilation (IMV).
Measured: 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)
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.
Measured: Baseline (within 24 hours before randomization) and Day 28 after randomization
Change in Diaphragm Thickening Fraction (TFdi) from 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.
Measured: Baseline to Day 28
Change in Diaphragm Thickness (DT) Measured by B-mode Ultrasound from Baseline to Day 28 (mm)
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.
Measured: Baseline to Day 28
Weaning Success From Invasive Mechanical Ventilation Within 28 Days (% of Participants)
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.
Measured: Up to Day 28 after randomization
28-Day In-hospital Cost From Randomization (CNY)
Total in-hospital cost (Chinese Yuan) during the first 28 days after randomization
Measured: exactly 28 days
Change in PEF from Baseline to Day 28 (L/min)
Measured: Baseline to Day 28
Readmission
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.
Measured: Readmission of 3 month/6 month/ 12 month
mortality
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.
Measured: mortality of 3 month/6 month/ 12 month
Incidence of pulmonary infection
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.
Measured: Incidence of pulmonary infection of 3 months/ 6 months/ 12 months
Ventilator-Free Days to Day 28 (VFDs-28)
Measured: Day 0-28 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start29 Sep 2025
- Primary completion1 Nov 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Rehabilitation Hospital of Capital Medical University
- Responsible party
- Principal investigator, Yi Li, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199036
- Sponsor's protocol ID
- 2025bkky
- Status last verified
- Oct 2025
- First submitted
- 29 Sep 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of the Effect of Respiratory Muscles Electrical Stimulation on Weaning in Patients With Difficult Weaning of the Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07199036
- Acronym / sponsor ID
- 2025bkky
- Conditions
- Mechanical Ventilation
- Keywords
- Prolonged Mechanical Ventilation, transcutaneous phrenic nerve electrical stimulation, abdominal functional electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Rehabilitation Hospital of Capital Medical University
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Device: Sham TEDS, Device: Sham abFESSham TEDS + Sham abFES + Standard Care |
| TEDS Only | Experimental | Device: TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation), Device: Sham abFESTEDS + Sham abFES |
| abFES Only | Experimental | Device: abFES (Functional Electrical Stimulation of Abdominal Muscles), Device: Sham TEDSabFES + Sham TEDS |
| Combined | Experimental | Device: TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation), Device: abFES (Functional Electrical Stimulation of Abdominal Muscles)TEDS + abFES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation)Per session 20 min, twice daily; 5 days/week; up to 28 days or until successful weaning. | Device | Combined, TEDS Only |
| abFES (Functional Electrical Stimulation of Abdominal Muscles)Per session 20 min, twice daily | Device | Combined, abFES Only |
| Sham TEDSPosition/time matched; 2 Hz low-intensity sensation only; no visible contraction. | Device | Control, abFES Only |
| Sham abFESPosition/time matched; sensation only; no visible contraction. | Device | Control, TEDS Only |
Primary outcome
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).
10 secondary outcomes
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
Change in Diaphragm Thickening Fraction (TFdi) from Baseline to Day 28 (%)
Time frame: Baseline to Day 28
Change in Diaphragm Thickness (DT) Measured by B-mode Ultrasound from Baseline to Day 28 (mm)
Time frame: Baseline to Day 28
Weaning Success From Invasive Mechanical Ventilation Within 28 Days (% of Participants)
Time frame: Up to Day 28 after randomization
28-Day In-hospital Cost From Randomization (CNY)
Time frame: exactly 28 days
Change in PEF from Baseline to Day 28 (L/min)
Time frame: Baseline to Day 28
Readmission
Time frame: Readmission of 3 month/6 month/ 12 month
mortality
Time frame: mortality of 3 month/6 month/ 12 month
Incidence of pulmonary infection
Time frame: Incidence of pulmonary infection of 3 months/ 6 months/ 12 months
Ventilator-Free Days to Day 28 (VFDs-28)
Time frame: Day 0-28 after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation) and abFES (Functional Electrical Stimulation of Abdominal Muscles) in people with Mechanical Ventilation, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Successful Weaning (days) (time frame: From randomization up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.