Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
NCT Number: NCT07309783
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The EIT-guided group, will receive recruitment maneuver and PEEP titration guided by EIT to determine the optimal PEEP level.
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.
The EIT-guided group, will determine prone positioning therapy based on EIT.
The control group will determine prone positioning therapy based on routine practice.
Time frame: Day 28 after randomization
The survival status on the 28th day after randomization
Time frame: within 28 days after randomization
Ventilator-free days within 28 days after randomization
Time frame: Within 14 days after randomization
Ventilator-free days within 14 days after randomization
Contact information is provided by the study sponsor or research team.
Huaiwu He, MD
CONTACT
Siyi Yuan, MD
CONTACT
Peking Union Medical College Hospital
Other
Personalised EIT-guided Ventilation Strategy Versus Conventional Protective Ventilation Strategy in ARDS Patients: a Multicenter, Randomized, Controlled triaL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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