NCT07309783 Lung EIT Image Guide Ventilation in ARDS
| NCT ID | NCT07309783 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | ARDS (Acute Respiratory Distress Syndrome) |
| Study Type | INTERVENTIONAL |
| Enrollment | 574 participants |
| Start Date | 2026-03-24 |
| Primary Completion | 2028-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 574 participants in total. It began in 2026-03-24 with a primary completion date of 2028-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * Patients with ARDS receiving mechanical ventilation who meet the following diagnostic 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: * 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.
Contact & Investigator
Huaiwu He, MD
STUDY CHAIR
Department of Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT07309783 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ARDS (Acute Respiratory Distress Syndrome). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07309783 currently recruiting?
Yes, NCT07309783 is actively recruiting participants. Contact the research team at tjmuhhw@163.com for enrollment information.
Where is the NCT07309783 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07309783 clinical trial?
NCT07309783 is sponsored by Peking Union Medical College Hospital. The principal investigator is Huaiwu He, MD at Department of Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 574 participants.