NCT07309783

Lung EIT Image Guide Ventilation in ARDS

Personalised EIT-guided Ventilation Strategy Versus Conventional Protective Ventilation Strategy in ARDS Patients: a Multicenter, Randomized, Controlled triaL

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 574 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ARDS (Acute Respiratory Distress Syndrome)

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.
BEHAVIORAL	Prone positioning guided by EIT	The EIT-guided group, will determine prone positioning therapy based on EIT.
BEHAVIORAL	Prone positioning according to routine practice	The control group will determine prone positioning therapy based on routine practice.

Timeline

• Start date: 2025-12-20
• Primary completion: 2028-12-20
• Completion: 2029-06-20
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: China