ARDS (Acute Respiratory Distress Syndrome)NCT07309783
Lung EIT Image Guide Ventilation in ARDS
A study testing Recruitment maneuver and PEEP setting guided by EIT, PEEP setting according to routine practice and Prone positioning guided by EIT in people with ARDS (Acute Respiratory Distress Syndrome), run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this multi-center randomized controlled clinical trial is to learn if an individualized, bedside electrical impedance tomography (EIT)-guided ventilation strategy (including EIT-guided prone positioning and PEEP titration) can improve outcomes compared with a conventional lung-protective ventilation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- Recruitment maneuver and PEEP setting guided by EIT, PEEP setting according to routine practice and Prone positioning guided by EIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 574 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2026to 20 Jun 2029
- 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
- Patients with ARDS receiving mechanical ventilation who meet the following diagnostic criteria:
- Triggered by acute risk factors such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock. Pulmonary edema is not entirely or predominantly attributable to cardiogenic causes or fluid overload, and hypoxemia/gas exchange impairment is not mainly due to atelectasis. However, ARDS can be diagnosed in the presence of these conditions if predisposing risk factors exist.
- Acute onset or worsening of hypoxemic respiratory failure within 1 week of the identified risk factor or onset of new or worsening respiratory symptoms.
- Bilateral opacities on chest radiograph or CT, or bilateral B-lines and/or consolidation on ultrasound, not fully explained by effusion, atelectasis, or nodules/masses.
- PaO₂/FiO₂ ≤ 300 mm Hg or SpO₂/FiO₂ ≤ 315 (if SpO₂ ≤ 97%).
- ARDS onset within 1 week.
- Mechanical ventilation ≤ 72 hours.
Who cannot join
- Age < 18 years.
- Pregnancy.
- Contraindications to EIT application (e.g., local skin lesions, cardiac pacemaker).
- Contraindications to prone positioning (e.g., increased intracranial pressure, intra-abdominal hypertension, spinal fractures).
- Evidence of barotrauma such as pneumothorax, mediastinal emphysema, or subcutaneous emphysema.
- End-stage disease.
- Informed consent not signed by legal guardians or family.
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
Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
Huaiwu He, MD, 86-010-69152300, tjmuhhw@163.com
About this study
Official title: Personalised EIT-guided Ventilation Strategy Versus Conventional Protective Ventilation Strategy in ARDS Patients: a Multicenter, Randomized, Controlled triaL
The goal of this multi-center randomized controlled clinical trial is to learn if an individualized, bedside electrical impedance tomography (EIT)-guided ventilation strategy (including EIT-guided prone positioning and PEEP titration) can improve outcomes compared with a conventional lung-protective ventilation strategy in adult patients with acute respiratory distress syndrome (ARDS).
The main questions it aims to answer are:
Read more
Does the individualized EIT-guided ventilation strategy reduce 28-day mortality in ARDS patients? Researchers will compare the EIT-guided intervention arm to a control arm receiving routine lung-protective ventilation (without bedside EIT guidance) to see if the EIT-guided approach lowers 28-day mortality and improves other clinical outcomes.
Adult ARDS patients who meet inclusion criteria will be assigned to EIT-guided group and control group through stratified randomization:
EIT-guided group: Undergo bedside EIT assessments using a China-manufactured EIT device to guide decisions about prone positioning and individualized PEEP titration (including a recruitment maneuver).
Control group: Receive PEEP setting per conventional PEEP-FiO₂ tables and prone positioning per standard clinical indications without EIT guidance.
Both groups: Receive standard supportive ICU care and routine outcome assessments at multiple time points.
Primary outcome: 28-day mortality. Other outcomes include ventilator-free days to day 28 and so on.
- Being tested
- Recruitment maneuver and PEEP setting guided by EIT, PEEP setting according to routine practice, Prone positioning guided by EIT, Prone positioning according to routine practice
- Keywords
- ARDS, EIT-guided ventilation strategy, EIT-guided prone positioning, EIT-guided PEEP setting, RCT
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment maneuver and PEEP setting guided by EITOther
The EIT-guided group, will receive recruitment maneuver and PEEP titration guided by EIT to determine the optimal PEEP level.
PEEP setting according to routine practiceOther
The control group will receive routine ventilation strategy. Routine recruitment maneuver is not recommended but may be used as rescue therapy. PEEP is set using the conventional PEEP-FiO₂ table.
Prone positioning guided by EITBehavioural
The EIT-guided group, will determine prone positioning therapy based on EIT.
Prone positioning according to routine practiceBehavioural
The control group will determine prone positioning therapy based on routine practice.
| Study group | Role | What they receive |
|---|---|---|
| EIT-guided group | Experimental | Prone positioning and PEEP titration guided by China-manufactured EIT. Receives: Other: Recruitment maneuver and PEEP setting guided by EIT; Behavioral: Prone positioning guided by EIT |
| Control group | Active comparator | PEEP set guided by conventional PEEP-FiO₂ table and prone positioning guided by routine clinical indications without EIT guidance. Receives: Other: PEEP setting according to routine practice; Behavioral: Prone positioning according to routine practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
The survival status on the 28th day after randomization
Measured: Day 28 after randomization
Secondary outcomes (2)
Ventilator-free days within 28 days after randomization
Ventilator-free days within 28 days after randomization
Measured: within 28 days after randomization
Ventilator-free days within 14 days after randomization
Ventilator-free days within 14 days after randomization
Measured: Within 14 days 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 Dec 2025
- Study start24 Mar 2026
- Primary completion20 Dec 2028 (estimated)
- Study completion20 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 574 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huaiwu He, MD, Study chair, Department of Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309783
- Sponsor's protocol ID
- PEARL
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised EIT-guided Ventilation Strategy Versus Conventional Protective Ventilation Strategy in ARDS Patients: a Multicenter, Randomized, Controlled triaL
- ClinicalTrials.gov ID
- NCT07309783
- Acronym / sponsor ID
- PEARL
- Keywords
- ARDS, EIT-guided ventilation strategy, EIT-guided prone positioning, EIT-guided PEEP setting, RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 574 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 20 Dec 2028 (estimated)
- Study completion
- 20 Jun 2029 (estimated)
- First posted
- 30 Dec 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.
The goal of this multi-center randomized controlled clinical trial is to learn if an individualized, bedside electrical impedance tomography (EIT)-guided ventilation strategy (including EIT-guided prone positioning and PEEP titration) can improve outcomes compared with a conventional lung-protective ventilation strategy in adult patients with acute respiratory distress syndrome (ARDS).
The main questions it aims to answer are:
Does the individualized EIT-guided ventilation strategy reduce 28-day mortality in ARDS patients? Researchers will compare the EIT-guided intervention arm to a control arm receiving routine lung-protective ventilation (without bedside EIT guidance) to see if the EIT-guided approach lowers 28-day mortality and improves other clinical outcomes.
Adult ARDS patients who meet inclusion criteria will be assigned to EIT-guided group and control group through stratified randomization:
EIT-guided group: Undergo bedside EIT assessments using a China-manufactured EIT device to guide decisions about prone positioning and individualized PEEP titration (including a recruitment maneuver).
Control group: Receive PEEP setting per conventional PEEP-FiO₂ tables and prone positioning per standard clinical indications without EIT guidance.
Both groups: Receive standard supportive ICU care and routine outcome assessments at multiple time points.
Primary outcome: 28-day mortality. Other outcomes include ventilator-free days to day 28 and so on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EIT-guided group | Experimental | Other: Recruitment maneuver and PEEP setting guided by EIT, Behavioral: Prone positioning guided by EITProne positioning and PEEP titration guided by China-manufactured EIT. |
| Control group | Active comparator | Other: PEEP setting according to routine practice, Behavioral: Prone positioning according to routine practicePEEP set guided by conventional PEEP-FiO₂ table and prone positioning guided by routine clinical indications 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 (7 listed)
- Patients with ARDS receiving mechanical ventilation who meet the following diagnostic criteria:
- ARDS onset within 1 week.
- Mechanical ventilation ≤ 72 hours.
Key exclusion criteria (7 listed)
- Age < 18 years.
- Pregnancy.
- Contraindications to EIT application (e.g., local skin lesions, cardiac pacemaker).
- Contraindications to prone positioning (e.g., increased intracranial pressure, intra-abdominal hypertension, spinal fractures).
- Evidence of barotrauma such as pneumothorax, mediastinal emphysema, or subcutaneous emphysema.
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 |
|---|---|---|
| Recruitment maneuver and PEEP setting guided by EITThe EIT-guided group, will receive recruitment maneuver and PEEP titration guided by EIT to determine the optimal PEEP level. | Other | EIT-guided group |
| PEEP setting according to routine practiceThe control group will receive routine ventilation strategy. Routine recruitment maneuver is not recommended but may be used as rescue therapy. PEEP is set using the conventional PEEP-FiO₂ table. | Other | Control group |
| Prone positioning guided by EITThe EIT-guided group, will determine prone positioning therapy based on EIT. | Behavioural | EIT-guided group |
| Prone positioning according to routine practiceThe control group will determine prone positioning therapy based on routine practice. | Behavioural | Control group |
Primary outcome
28-day mortality
Time frame: Day 28 after randomization
The survival status on the 28th day after randomization
2 secondary outcomes
Ventilator-free days within 28 days after randomization
Time frame: within 28 days after randomization
Ventilator-free days within 14 days after randomization
Time frame: Within 14 days after randomization
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 9 Jul 2026.
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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.
Huaiwu He, MD study chair
Department of Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recruitment maneuver and PEEP setting guided by EIT, PEEP setting according to routine practice and Prone positioning guided by EIT in people with ARDS (Acute Respiratory Distress Syndrome), run by Peking Union Medical College Hospital 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 7 inclusion and 7 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 9 Jul 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 Huaiwu He, MD (86-010-69152300, tjmuhhw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: Day 28 after randomization). 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 9 Jul 2026.