Lung EIT Image Guide Ventilation in ARDS

NCT07309783 | Not Yet Recruiting

• 1 other identifier: PEARL
• Study Type: interventional
• Target: 574
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Keywords

ARDS; EIT-guided ventilation strategy; EIT-guided prone positioning; EIT-guided PEEP setting; RCT

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  The survival status on the 28th day after randomization

  Day 28 after randomization

Secondary Outcomes (2)

• Ventilator-free days within 28 days after randomization

  within 28 days after randomization

• Ventilator-free days within 14 days after randomization

  Within 14 days after randomization

Study Arms (2)

EIT-guided group

EXPERIMENTAL

Prone positioning and PEEP titration guided by China-manufactured EIT.

Other: Recruitment maneuver and PEEP setting guided by EIT; Behavioral: Prone positioning guided by EIT

Control group

ACTIVE COMPARATOR

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; Behavioral: Prone positioning according to routine practice

Interventions

PEEP setting according to routine practice OTHER

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.

Control group

Prone positioning guided by EIT BEHAVIORAL

The EIT-guided group, will determine prone positioning therapy based on EIT.

EIT-guided group

Prone positioning according to routine practice BEHAVIORAL

The control group will determine prone positioning therapy based on routine practice.

Control group

Recruitment maneuver and PEEP setting guided by EIT OTHER

The EIT-guided group, will receive recruitment maneuver and PEEP titration guided by EIT to determine the optimal PEEP level.

EIT-guided group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ARDS receiving mechanical ventilation who meet the following diagnostic criteria:
• 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.
• Acute onset or worsening of hypoxemic respiratory failure within 1 week of the identified risk factor or onset of new or worsening respiratory symptoms.
• 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.
• PaO₂/FiO₂ ≤ 300 mm Hg or SpO₂/FiO₂ ≤ 315 (if SpO₂ ≤ 97%).
• ARDS onset within 1 week.
• Mechanical ventilation ≤ 72 hours.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

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

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Huaiwu He, MD

  Department of Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Huaiwu He, MD

CONTACT

86-010-69152300; tjmuhhw@163.com

Siyi Yuan, MD

CONTACT

86-010-69152300; yuansiyi@pumch.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): June 20, 2029
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CN (1)