Prolonged Mechanical VentilationPMVNCT07372794
EIT-Guided Respiratory Physiotherapy for Prolonged Mechanical Ventilation (PMV)
A study testing EIT-Guided Respiratory Physiotherapy and Conventional Respiratory Physiotherapy in people with Prolonged Mechanical Ventilation and Respiratory Failure, run by Capital Medical University at 1 site in China.
Trial summary
Patients with prolonged mechanical ventilation (PMV) frequently experience impaired ventilation distribution, respiratory muscle dysfunction, secretion retention, and delayed liberation from mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Mechanical Ventilation, Respiratory Failure, Critical Illness
- What is being tested?
- EIT-Guided Respiratory Physiotherapy and Conventional Respiratory Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2026to 15 Dec 2026
- 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
- Age ≥ 18 years.
- Invasive mechanical ventilation for ≥ 21 consecutive days.
- Clinically stable and eligible for respiratory physiotherapy as determined by the treating team.
- Expected to remain on invasive mechanical ventilation for at least 48 hours after enrollment.
- Written informed consent obtained from the patient or legally authorized representative.
Who cannot join
- Contraindications to electrical impedance tomography .
- Hemodynamic instability requiring high-dose vasoactive support.
- Severe hypoxemia refractory to optimization.
- Unstable fractures or other contraindications to mobilization or positioning.
- Pregnancy.
- Expected death within 48 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Rehabilitation Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100144
About this study
Official title: Electrical Impedance Tomography-Guided Respiratory Physiotherapy for Liberation From Prolonged Mechanical Ventilation: A Multicenter Randomized Controlled Trial
Patients with prolonged mechanical ventilation (PMV) frequently experience impaired ventilation distribution, respiratory muscle dysfunction, secretion retention, and delayed liberation from mechanical ventilation. Electrical impedance tomography (EIT) provides real-time bedside visualization of regional ventilation and enables individualized respiratory physiotherapy strategies.
This multicenter randomized controlled trial aims to evaluate whether EIT-guided respiratory physiotherapy improves ventilator-free days at day 28 compared with conventional respiratory physiotherapy in adult patients with PMV.
Read more
Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning. In the EIT-guided group, real-time EIT imaging is used to individualize physiotherapy strategies based on predefined ventilation distribution indicators, while the control group receives standardized physiotherapy according to institutional protocols without EIT guidance.
Secondary outcomes include successful liberation from mechanical ventilation, diaphragm ultrasound parameters, EIT-derived ventilation distribution indices (exploratory mechanistic outcomes), ICU Mobility Scale, healthcare resource utilization, and safety outcomes.
Read the detailed description
This multicenter randomized controlled trial evaluates the effectiveness of electrical impedance tomography (EIT)-guided respiratory physiotherapy compared with conventional respiratory physiotherapy in adult patients with prolonged mechanical ventilation (PMV).
Eligible patients receiving invasive mechanical ventilation for at least 21 consecutive days will be randomly assigned in a 1:1 ratio to either the EIT-guided group or the control group, in addition to standard ICU care.
Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning. Both groups will receive standardized physiotherapy protocols with comparable treatment frequency and duration.
In the EIT-guided group, real-time EIT imaging will be used during each physiotherapy session. The control group will receive the same standardized physiotherapy components according to institutional protocols without EIT guidance.
The primary outcome is ventilator-free days at day 28 (VFD-28), defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization. Patients who die before day 28 or remain invasively ventilated at day 28 will be assigned a value of zero. Reintubation within 72 hours will be considered treatment failure according to the predefined protocol.
Secondary outcomes include successful liberation from invasive mechanical ventilation by day 28, diaphragm ultrasound parameters, EIT-derived ventilation distribution indices (exploratory mechanistic outcomes), ICU Mobility Scale (IMS), healthcare resource utilization, and safety outcomes.
EIT-derived parameters are included as exploratory mechanistic outcomes to characterize physiological responses to the intervention and are not used for primary outcome adjudication.
- Being tested
- EIT-Guided Respiratory Physiotherapy, Conventional Respiratory Physiotherapy
- Keywords
- Electrical Impedance Tomography, Prolonged Mechanical Ventilation, Respiratory Physiotherapy, Ventilator Weaning, Ventilator-Free Days
- Medical subject headings
- Respiratory Insufficiency, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIT-Guided Respiratory PhysiotherapyOther
Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning, individualized using real-time EIT guidance based on predefined ventilation distribution indicators. Link this intervention to: Experimental Arm
Conventional Respiratory PhysiotherapyOther
Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning, delivered according to standardized institutional protocols without EIT guidance. Link this intervention to: Control Arm
| Study group | Role | What they receive |
|---|---|---|
| EIT-Guided Respiratory Physiotherapy | Experimental | Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning.
In the EIT-guided group, real-time electrical impedance tomography (EIT) imaging is used during each physiotherapy session to individualize patient positioning and the selection and sequencing of physiotherapy techniques based on predefined ventilation distribution indicators. Receives: Other: EIT-Guided Respiratory Physiotherapy |
| Conventional Respiratory Physiotherapy | Active comparator | Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning, delivered according to standardized institutional protocols without EIT guidance. Receives: Other: Conventional Respiratory Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-Free Days at Day 28 (VFD-28)
Ventilator-free days at day 28 (VFD-28) is defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization. Patients who die before day 28 or remain invasively ventilated at day 28 will be assigned a value of zero. Reintubation within 72 hours after extubation or decannulation is considered treatment failure according to the predefined protocol.
Measured: 28 days
Secondary outcomes (8)
Successful liberation from invasive mechanical ventilation by day 28
Successful liberation is defined as remaining free from invasive mechanical ventilation for at least 72 consecutive hours.
Measured: 28 days
Diaphragm ultrasound parameters
Diaphragmatic excursion, thickness, and thickening fraction measured by bedside ultrasound.
Measured: Up to 28 days
EIT-derived ventilation distribution indices
Regional ventilation distribution indices derived from electrical impedance tomography, analyzed as exploratory mechanistic outcomes and not used for primary outcome adjudication.
Measured: During intervention period (up to 28 days)
ICU Mobility Scale (IMS) change from baseline
Change in ICU Mobility Scale score from baseline to the highest achieved level during ICU stay.
Measured: Up to ICU discharge or day 28
ICU length of stay
Number of days from ICU admission to ICU discharge.
Measured: Up to hospital discharge
Hospital length of stay
Number of days from hospital admission to hospital discharge.
Measured: From hospital admission to hospital discharge
Total hospitalization cost
Total direct medical cost during hospitalization.
Measured: Up to hospital discharge
Adverse events during physiotherapy
Incidence of adverse events related to respiratory physiotherapy, including desaturation, hemodynamic instability, arrhythmia, or treatment intolerance.
Measured: During intervention period (up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start16 Feb 2026
- Primary completion14 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Mechanical VentilationStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Li, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372794
- Sponsor's protocol ID
- 2026bkky0115ly
- Acronym
- PMV
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography-Guided Respiratory Physiotherapy for Liberation From Prolonged Mechanical Ventilation: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07372794
- Acronym / sponsor ID
- PMV / 2026bkky0115ly
- Keywords
- Electrical Impedance Tomography, Prolonged Mechanical Ventilation, Respiratory Physiotherapy, Ventilator Weaning, Ventilator-Free Days
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 28 Jan 2026 (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.
Patients with prolonged mechanical ventilation (PMV) frequently experience impaired ventilation distribution, respiratory muscle dysfunction, secretion retention, and delayed liberation from mechanical ventilation. Electrical impedance tomography (EIT) provides real-time bedside visualization of regional ventilation and enables individualized respiratory physiotherapy strategies.
This multicenter randomized controlled trial aims to evaluate whether EIT-guided respiratory physiotherapy improves ventilator-free days at day 28 compared with conventional respiratory physiotherapy in adult patients with PMV.
Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning. In the EIT-guided group, real-time EIT imaging is used to individualize physiotherapy strategies based on predefined ventilation distribution indicators, while the control group receives standardized physiotherapy according to institutional protocols without EIT guidance.
Secondary outcomes include successful liberation from mechanical ventilation, diaphragm ultrasound parameters, EIT-derived ventilation distribution indices (exploratory mechanistic outcomes), ICU Mobility Scale, healthcare resource utilization, and safety outcomes.
Detailed description
This multicenter randomized controlled trial evaluates the effectiveness of electrical impedance tomography (EIT)-guided respiratory physiotherapy compared with conventional respiratory physiotherapy in adult patients with prolonged mechanical ventilation (PMV).
Eligible patients receiving invasive mechanical ventilation for at least 21 consecutive days will be randomly assigned in a 1:1 ratio to either the EIT-guided group or the control group, in addition to standard ICU care.
Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning. Both groups will receive standardized physiotherapy protocols with comparable treatment frequency and duration.
In the EIT-guided group, real-time EIT imaging will be used during each physiotherapy session. The control group will receive the same standardized physiotherapy components according to institutional protocols without EIT guidance.
The primary outcome is ventilator-free days at day 28 (VFD-28), defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization. Patients who die before day 28 or remain invasively ventilated at day 28 will be assigned a value of zero. Reintubation within 72 hours will be considered treatment failure according to the predefined protocol.
Secondary outcomes include successful liberation from invasive mechanical ventilation by day 28, diaphragm ultrasound parameters, EIT-derived ventilation distribution indices (exploratory mechanistic outcomes), ICU Mobility Scale (IMS), healthcare resource utilization, and safety outcomes.
EIT-derived parameters are included as exploratory mechanistic outcomes to characterize physiological responses to the intervention and are not used for primary outcome adjudication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EIT-Guided Respiratory Physiotherapy | Experimental | Other: EIT-Guided Respiratory PhysiotherapyRespiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning. In the EIT-guided group, real-time electrical impedance tomography (EIT) imaging is used during each physiotherapy session to individualize patient positioning and the selection and sequencing of physiotherapy techniques based on predefined ventilation distribution indicators. |
| Conventional Respiratory Physiotherapy | Active comparator | Other: Conventional Respiratory PhysiotherapyRespiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning, delivered according to standardized institutional protocols without EIT guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Invasive mechanical ventilation for ≥ 21 consecutive days.
- Clinically stable and eligible for respiratory physiotherapy as determined by the treating team.
- Expected to remain on invasive mechanical ventilation for at least 48 hours after enrollment.
- Written informed consent obtained from the patient or legally authorized representative.
Key exclusion criteria (6 listed)
- Contraindications to electrical impedance tomography .
- Hemodynamic instability requiring high-dose vasoactive support.
- Severe hypoxemia refractory to optimization.
- Unstable fractures or other contraindications to mobilization or positioning.
- Pregnancy.
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 |
|---|---|---|
| EIT-Guided Respiratory PhysiotherapyRespiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning, individualized using real-time EIT guidance based on predefined ventilation distribution indicators. Link this intervention to: Experimental Arm | Other | EIT-Guided Respiratory Physiotherapy |
| Conventional Respiratory PhysiotherapyRespiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning, delivered according to standardized institutional protocols without EIT guidance. Link this intervention to: Control Arm | Other | Conventional Respiratory Physiotherapy |
Primary outcome
Ventilator-Free Days at Day 28 (VFD-28)
Time frame: 28 days
Ventilator-free days at day 28 (VFD-28) is defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization. Patients who die before day 28 or remain invasively ventilated at day 28 will be assigned a value of zero. Reintubation within 72 hours after extubation or decannulation is considered treatment failure according to the predefined protocol.
8 secondary outcomes
Successful liberation from invasive mechanical ventilation by day 28
Time frame: 28 days
Diaphragm ultrasound parameters
Time frame: Up to 28 days
EIT-derived ventilation distribution indices
Time frame: During intervention period (up to 28 days)
ICU Mobility Scale (IMS) change from baseline
Time frame: Up to ICU discharge or day 28
ICU length of stay
Time frame: Up to hospital discharge
Hospital length of stay
Time frame: From hospital admission to hospital discharge
Total hospitalization cost
Time frame: Up to hospital discharge
Adverse events during physiotherapy
Time frame: During intervention period (up to 28 days)
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 4 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIT-Guided Respiratory Physiotherapy and Conventional Respiratory Physiotherapy in people with Prolonged Mechanical Ventilation and Respiratory Failure, 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 May 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. 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 Yi Li (86 13810913780, liyi_bjkfyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-Free Days at Day 28 (VFD-28) (time frame: 28 days). 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 4 May 2026.