Difficult-to-Wean PatientsNCT06677099
Electrical Impedance Tomography in Guiding Early and Precise Rehabilitation of Patients with Difficult Ventilator Weaning
A study testing chest physiotherapy and EIT-guided chest physiotherapy in people with Difficult-to-Wean Patients, run by Capital Medical University.
Trial summary
Diaphragm dysfunction, ineffective chest wall and respiratory muscle function are frequently observed in critically ill patients with difficult weaning from mechanical ventilation(MV).It is the leading cause of retention of airway secretions and insufficient airway clearance.Thechest physiotherapy (CPT) of critically… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult-to-Wean Patients
- What is being tested?
- chest physiotherapy and EIT-guided chest physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 7 Nov 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- mechanical ventilation patients who are ≥18 years old, are received to invasive mechanical ventilation more than 96 hours before randomization, are meted the preconditions for the machine to be withdrawn, and at least have one failed attempt to withdraw the ventilator (re-need ventilator support within 48 hours after extubation),
- willing to participate in the study and sign the informed consentsent.
Who cannot join
- Malignant arrhythmia or acute myocardial ischemia
- Pneumothorax, pulmonary bulla and barotrauma and other lung diseases
- Hemorrhagic disease or abnormal coagulation mechanism with bleeding tendency
- Chest skin trauma
- Pulmonary hypertension and pulmonary embolism
- With a permanent or temporary pacemaker
Show all 10Show fewer
- There is malignant tumor
- Present and previous history of neuromuscular diseases affecting respiratory muscle
- Participated in another clinical study related to mechanical ventilation withdrawal
- Can not cooperate with the study for any reason or the researcher thinks that it is not suitable to be included in this experiment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jingyi Ge contact
About this study
Official title: Electrical Impedance Tomography in Guiding Early and Precise Rehabilitation of Patients with Difficult Ventilator Weaning:A Single-cente Randomised Controlled Trial
Diaphragm dysfunction, ineffective chest wall and respiratory muscle function are frequently observed in critically ill patients with difficult weaning from mechanical ventilation(MV).It is the leading cause of retention of airway secretions and insufficient airway clearance.Thechest physiotherapy (CPT) of critically ill patients can reduce secretion retention. We designed a protocol to investigate the feasibility and efficacy of CPT guided by electrical impedance tomography (EIT) in Difficult-to-Wean patients.
- Conditions
- Difficult-to-Wean Patients
- Being tested
- chest physiotherapy, EIT-guided chest physiotherapy
- Keywords
- mechanical ventilation, electrical impedance tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest physiotherapyProcedure or surgery
Two sessions of CPT (morning and afternoon, 20 minutes each) were conducted. The CPT session consisted of modified postural drainage, assisted cough technique , positive expiratory pressure and chest percussion, vibration. The appointed therapist performed pulmonary auscultation and thoracic palpation to assess the status of pulmonary ventilation and secretion retention, and whether the patient's cough ability can complete effective airway clearance. Individualized program was formed according to the assessment, internal guidelines, the patient's tolerance, education level, and patient's preference prior to the randomization. All CPT sessions were performed by the same physiotherapist to avoid potential bias.
EIT-guided chest physiotherapyProcedure or surgery
EIT-guided modified postural drainage combined with vibrations and chest percussion: tidal variation images in EIT reveals heterogeneously ventilated regions. Physiotherapist identified such regions at the bedside and instructed the patient to take the appropriate drainage position, so that the poorly ventilated regions became gravity non-dependent regions. Subsequently, the physiotherapist put her hands on the poorly ventilated area with a vibratory force. A compressive pressure was produced by the therapist's arms.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Two sessions of CPT (morning and afternoon, 20 minutes each) were conducted. The CPT session consisted of modified postural drainage, assisted cough technique, positive expiratory pressure and chest percussion, vibration. The appointed therapist performed pulmonary auscultation and thoracic palpation to assess the status of pulmonary ventilation and secretion retention, and whether the patient's cough ability can complete effective airway clearance. Individualized program was formed according to the assessment, internal guidelines, the patient's tolerance, education level, and patient's preference prior to the randomization. All CPT sessions were performed by the same physiotherapist to avoid potential bias. Receives: Procedure: chest physiotherapy |
| EIT-guided group | Experimental | EIT-guided group: Similar to the patients in the Control group, the CPT techniques were predefined for the patients according to the assessment prior to the randomization. For each CPT session, EIT measurement was conducted and the images were used to guide the CPT treatments. The uses of EIT to guide individual treatments are briefly described as follows. Receives: Procedure: EIT-guided chest physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak expiratory flow
Measured: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Secondary outcomes (6)
The cumulative incidence of successful weaning by Day 30
Measured: from admission to discharge, assessed up to 1 day
Maximum inspiratory pressure
Measured: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Diaphragm thickening rate
Measured: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Diaphragmatic excursion
Measured: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Length of ICU stay
Measured: from admission to discharge, assessed up to 1 day
Cumulative incidence for death before successful weaning
Measured: from admission to discharge, assessed up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start7 Nov 2024 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Difficult-to-Wean PatientsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyi Ge, Capital Medical University
- Investigators
- Jingyi Ge, Principal investigator, Beijing Rehabilitation Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677099
- Sponsor's protocol ID
- 2022-030
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang H, Xi J, Jiang H. Randomized clinical study of electrical impedance tomography-guided chest physiotherapy in difficult-to-wean patients: study protocol. PeerJ. 2025 Aug 4;13:e19727. doi: 10.7717/peerj.19727. eCollection 2025.
PubMed 40777077
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography in Guiding Early and Precise Rehabilitation of Patients with Difficult Ventilator Weaning:A Single-cente Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06677099
- Acronym / sponsor ID
- 2022-030
- Conditions
- Difficult-to-Wean Patients
- Keywords
- mechanical ventilation, electrical impedance tomography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 7 Nov 2024 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 6 Nov 2024 (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.
Diaphragm dysfunction, ineffective chest wall and respiratory muscle function are frequently observed in critically ill patients with difficult weaning from mechanical ventilation(MV).It is the leading cause of retention of airway secretions and insufficient airway clearance.Thechest physiotherapy (CPT) of critically ill patients can reduce secretion retention. We designed a protocol to investigate the feasibility and efficacy of CPT guided by electrical impedance tomography (EIT) in Difficult-to-Wean patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Procedure: chest physiotherapyTwo sessions of CPT (morning and afternoon, 20 minutes each) were conducted. The CPT session consisted of modified postural drainage, assisted cough technique, positive expiratory pressure and chest percussion, vibration. The appointed therapist performed pulmonary auscultation and thoracic palpation to assess the status of pulmonary ventilation and secretion retention, and whether the patient's cough ability can complete effective airway clearance. Individualized program was formed according to the assessment, internal guidelines, the patient's tolerance, education level, and patient's preference prior to the randomization. All CPT sessions were performed by the same physiotherapist to avoid potential bias. |
| EIT-guided group | Experimental | Procedure: EIT-guided chest physiotherapyEIT-guided group: Similar to the patients in the Control group, the CPT techniques were predefined for the patients according to the assessment prior to the randomization. For each CPT session, EIT measurement was conducted and the images were used to guide the CPT treatments. The uses of EIT to guide individual treatments are briefly described as follows. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mechanical ventilation patients who are ≥18 years old, are received to invasive mechanical ventilation more than 96 hours before randomization, are meted the preconditions for the machine to be withdrawn, and at least have one failed attempt to withdraw the ventilator (re-need ventilator support within 48 hours after extubation),
- willing to participate in the study and sign the informed consentsent.
Key exclusion criteria (10 listed)
- Malignant arrhythmia or acute myocardial ischemia
- Pneumothorax, pulmonary bulla and barotrauma and other lung diseases
- Hemorrhagic disease or abnormal coagulation mechanism with bleeding tendency
- Chest skin trauma
- Pulmonary hypertension and pulmonary embolism
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 |
|---|---|---|
| chest physiotherapyTwo sessions of CPT (morning and afternoon, 20 minutes each) were conducted. The CPT session consisted of modified postural drainage, assisted cough technique , positive expiratory pressure and chest percussion, vibration. The appointed therapist performed pulmonary auscultation and thoracic palpation to assess the status of pulmonary ventilation and secretion retention, and whether the patient's cough ability can complete effective airway clearance. Individualized program was formed according to the assessment, internal guidelines, the patient's tolerance, education level, and patient's preference prior to the randomization. All CPT sessions were performed by the same physiotherapist to avoid potential bias. | Procedure or surgery | Control group |
| EIT-guided chest physiotherapyEIT-guided modified postural drainage combined with vibrations and chest percussion: tidal variation images in EIT reveals heterogeneously ventilated regions. Physiotherapist identified such regions at the bedside and instructed the patient to take the appropriate drainage position, so that the poorly ventilated regions became gravity non-dependent regions. Subsequently, the physiotherapist put her hands on the poorly ventilated area with a vibratory force. A compressive pressure was produced by the therapist's arms. | Procedure or surgery | EIT-guided group |
Primary outcome
peak expiratory flow
Time frame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
6 secondary outcomes
The cumulative incidence of successful weaning by Day 30
Time frame: from admission to discharge, assessed up to 1 day
Maximum inspiratory pressure
Time frame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Diaphragm thickening rate
Time frame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Diaphragmatic excursion
Time frame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Length of ICU stay
Time frame: from admission to discharge, assessed up to 1 day
Cumulative incidence for death before successful weaning
Time frame: from admission to discharge, assessed up to 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Derived from this study: PubMed 40777077Wang H, Xi J, Jiang H. Randomized clinical study of electrical impedance tomography-guided chest physiotherapy in difficult-to-wean patients: study protocol. PeerJ. 2025 Aug 4;13:e19727. doi: 10.7717/peerj.19727. eCollection 2025.
- 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.
Jingyi Ge contact
Jingyi Ge principal investigator
Beijing Rehabilitation Hospital of Capital Medical University
Questions about this trial
What is this clinical trial studying?
A study testing chest physiotherapy and EIT-guided chest physiotherapy in people with Difficult-to-Wean Patients, run by Capital Medical University.
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 10 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: opening soon, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingyi Ge (ge_jingyi2020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak expiratory flow (time frame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06677099, which also lists 1 linked publication.
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 6 Nov 2024.