Early EIT-Guided PEEP Titration on Pulmonary Physiology in Patients With Moderate-to-Severe ARDS Undergoing Prone Positioning (EIT-PEEP-PRONE)

NCT07793565 · tracked via the Priya Life Science China tracker

Sponsor

XIE MIN

Phase

Not applicable

Started

2026-08-31

Last updated

2026-08-28

Condition(s) studied

Acute Respiratory Distress Syndrome (ARDS)

Investigational drug(s) / intervention(s)

EIT-Guided PEEP Titration GroupARDSNet/PEEP-FiO₂ Table

EIT-Guided PEEP Titration Group: PEEP titration is performed during mechanical ventilation to optimize respiratory mechanics and ventilation-perfusion matching in patients with ARDS.

ARDSNet/PEEP-FiO₂ Table: PEEP will be set according to the ARDSNet/PEEP-FiO₂ table at 4 hours after prone positioning initiation (T1).

Study summary

Background: Electrical impedance tomography (EIT)-guided PEEP titration has been shown to improve regional ventilation distribution, increase respiratory system compliance, and reduce mechanical power in patients with acute respiratory distress syndrome (ARDS), but its effect on mortality remains unproven. In patients with moderate-to-severe ARDS, prone positioning for 4 hours allows pulmonary ventilation and perfusion to reach a new steady state, with optimization of ventilation-perfusion (V/Q) matching and other pulmonary physiological parameters. However, whether dynamic PEEP titration guided by EIT at this time point can further optimize V/Q matching and other pulmonary physiological parameters compared with conventional methods has not been reported.

Objective: To investigate whether EIT-guided PEEP titration performed at 4 hours after prone positioning initiation can further optimize V/Q matching and other pulmonary physiological parameters in patients with moderate-to-severe ARDS undergoing prone positioning.

Methods: This is a prospective, single-center, randomized, open-label, parallel-controlled physiological study. A total of 40 patients with moderate-to-severe ARDS (Berlin definition, PaO₂/FiO₂ \< 150 mmHg) will be enrolled and randomized in a 1:1 ratio to either the EIT-guided group or the control group. PEEP intervention will be performed at 4 hours after prone positioning initiation (T1) in both groups: the EIT group receives EIT-guided PEEP titration, while the control group receives PEEP set according to the ARDSNet/PEEP-FiO₂ table. The primary outcome is V/Q matching percentage assessed by EIT at 18 hours of prone positioning (T2) and 6 hours after supine repositioning (T3). Secondary outcomes include respiratory mechanics, EIT-derived parameters (regional ventilation distribution, global inhomogeneity index, center of ventilation), oxygenation indices, echocardiographic measures of cardiac function, and clinical outcomes (28-day mortality, ventilator-free days, ICU length of stay, etc.).

Conclusion: This study will provide physiological evidence for early EIT-guided PEEP titration in patients with moderate-to-severe ARDS undergoing prone positioning, and will lay the foundation for future large-scale clinical trials.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Diagnosis of moderate-to-severe ARDS according to the Berlin definition, with a PaO₂/FiO₂ ratio \< 150 mmHg on optimal mechanical ventilation. 2. Clinical decision has been made to place a central venous catheter (internal jugular or subclavian vein) for clinical management. Exclusion Criteria: 1. Pregnancy or postpartum state. 2. BMI \> 35 kg/m². 3. Duration of invasive mechanical ventilation \> 48 hours at enrollment. 4. Severe hemodynamic instability (mean arterial pressure \< 65 mmHg on norepinephrine ≥ 0.5 μg/kg/min). 5. Immediate need for veno-venous extracorporeal membrane oxygenation (VV-ECMO) at enrollment. 6. Contraindications to prone positioning or EIT monitoring, including but not limited to: facial or cervical trauma; unstable spinal, femoral, pelvic, or rib fractures; recent cardiac surgery; pneumothorax; elevated intracranial pressure; pacemaker or implantable cardioverter-defibrillator; severe chronic lung disease (e.g., severe COPD, asthma, interstitial lung disease); severe cardiac dysfunction (New York Heart Association Class III or IV, acute coronary syndrome, sustained ventricular tachyarrhythmia, or cardiogenic shock). 7. Lack of informed consent from legally authorized representative.

Primary outcome measure(s)

Ventilation-Perfusion (V/Q) Matching Percentage — At 18 hours of prone positioning (T2) and at 6 hours after supine repositioning (T3)
V/Q matching percentage assessed by electrical impedance tomography (EIT) using the EIT Evaluation Tool (SDMI) V2.7.1. V/Q matching reflects the efficiency of pulmonary gas exchange and is calculated from regional ventilation and perfusion distribution maps.

Trial sites (1)

Facility	City	Region	Status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07793565 on ClinicalTrials.gov ↗ ← All trials in China