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

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 Overview

• Status: Not yet recruiting
• Conditions: ARDS (Acute Respiratory Distress Syndrome)
• Intervention / Treatment: Other: Recruitment maneuver and PEEP setting guided by EIT; Behavioral: Prone positioning guided by EIT; Other: PEEP setting according to routine practice; Behavioral: Prone positioning according to routine practice

• Study Type: Interventional
• Enrollment (Estimated): 574
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huaiwu He, MD; Phone Number: 86-010-69152300; Email: tjmuhhw@163.com
• Study Contact Backup: Name: Siyi Yuan, MD; Phone Number: 86-010-69152300; Email: yuansiyi@pumch.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
      • Contact: Huaiwu He, MD; Phone Number: 86-010-69152300; Email: tjmuhhw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EIT-guided group; Prone positioning and PEEP titration guided by China-manufactured EIT.	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.; Behavioral: Prone positioning guided by EIT; The EIT-guided group, will determine prone positioning therapy based on EIT.
Active Comparator: Control group; PEEP set guided by conventional PEEP-FiO₂ table and prone positioning guided by routine clinical indications without EIT guidance.	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 according to routine practice; The control group will determine prone positioning therapy based on routine practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	The survival status on the 28th day after randomization	Day 28 after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator-free days within 28 days after randomization	Ventilator-free days within 28 days after randomization	within 28 days after randomization
Ventilator-free days within 14 days after randomization	Ventilator-free days within 14 days after randomization	Within 14 days after randomization

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Huaiwu He, MD, Department of Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2025
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): June 20, 2029

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ARDS; RCT; EIT-guided ventilation strategy; EIT-guided prone positioning; EIT-guided PEEP setting
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Injury; Acute Lung Injury
• Other Study ID Numbers: PEARL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No