Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
574 participants
INTERVENTIONAL
2025-12-20
2029-06-20
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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EIT-guided group
Prone positioning and PEEP titration guided by China-manufactured EIT.
Recruitment maneuver and PEEP setting guided by EIT
The EIT-guided group, will receive recruitment maneuver and PEEP titration guided by EIT to determine the optimal PEEP level.
Prone positioning guided by EIT
The EIT-guided group, will determine prone positioning therapy based on EIT.
Control group
PEEP set guided by conventional PEEP-FiO₂ table and prone positioning guided by routine clinical indications without EIT guidance.
PEEP setting according to routine practice
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 according to routine practice
The control group will determine prone positioning therapy based on routine practice.
Interventions
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Recruitment maneuver and PEEP setting guided by EIT
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 practice
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 EIT
The EIT-guided group, will determine prone positioning therapy based on EIT.
Prone positioning according to routine practice
The control group will determine prone positioning therapy based on routine practice.
Eligibility Criteria
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Inclusion Criteria
1. 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.
2. Acute onset or worsening of hypoxemic respiratory failure within 1 week of the identified risk factor or onset of new or worsening respiratory symptoms.
3. 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.
4. PaO₂/FiO₂ ≤ 300 mm Hg or SpO₂/FiO₂ ≤ 315 (if SpO₂ ≤ 97%).
* ARDS onset within 1 week.
* Mechanical ventilation ≤ 72 hours.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Huaiwu He, MD
Role: STUDY_CHAIR
Department of Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Locations
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Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Huaiwu He, MD
Role: primary
Other Identifiers
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PEARL
Identifier Type: -
Identifier Source: org_study_id