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NCT Number: NCT07793565

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

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome (ARDS) Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location contact

Min Xie, MD, PhD

CONTACT

[email protected]

+86-27-83665204

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of moderate-to-severe ARDS according to the Berlin definition, with a PaO₂/FiO₂ ratio < 150 mmHg on optimal mechanical ventilation.
  • Clinical decision has been made to place a central venous catheter (internal jugular or subclavian vein) for clinical management.

Exclusion criteria

  • Pregnancy or postpartum state.
  • BMI > 35 kg/m².
  • Duration of invasive mechanical ventilation > 48 hours at enrollment.
  • Severe hemodynamic instability (mean arterial pressure < 65 mmHg on norepinephrine ≥ 0.5 μg/kg/min).
  • Immediate need for veno-venous extracorporeal membrane oxygenation (VV-ECMO) at enrollment.
  • 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).
  • Lack of informed consent from legally authorized representative.

Treatment and study plan

EIT-Guided PEEP Titration Group

Other

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

ARDSNet/PEEP-FiO₂ Table

Other

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

Primary outcomes

  1. Ventilation-Perfusion (V/Q) Matching Percentage

    Time frame: 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.

Secondary outcomes

  1. Respiratory System Compliance

    Time frame: Baseline, T2 (18h prone), and T3 (6h post-supine)

    Respiratory system compliance (Crs) calculated as tidal volume divided by driving pressure (plateau pressure minus PEEP), measured under volume-controlled ventilation.

  2. Driving Pressure

    Time frame: At baseline (T0), at 18 hours of prone positioning (T2), and at 6 hours after supine repositioning (T3)

    Driving pressure (DP) calculated as plateau pressure (Pplat) minus PEEP, measured under volume-controlled ventilation.

  3. EIT-Derived Regional Ventilation Distribution

    Time frame: At baseline (T0), at 18 hours of prone positioning (T2), and at 6 hours after supine repositioning (T3)

    Regional ventilation distribution assessed by EIT, expressed as percentage of tidal impedance variation in four regions of interest (ROIs): ventral (ROI 1), mid-ventral (ROI 2), mid-dorsal (ROI 3), and dorsal (ROI 4), each corresponding to 25% of the anteroposterior diameter, Center of Ventilation (CoV), Global Inhomogeneity Index (GI), Shunt, Dead Space.

  4. RVEDA/LVEDA

    Time frame: At baseline (T0) and at 6 hours after supine repositioning (T3)

    Right Ventricular End-Diastolic Area to Left Ventricular End-Diastolic Area Ratio

  5. RVFAC

    Time frame: Baseline and 6h post-supine repositioning (T3)

    Right Ventricular Fractional Area Change（%）

  6. TAPSE

    Time frame: Baseline and 6h post-supine repositioning (T3)

    Tricuspid Annular Plane Systolic Excursion (mm)

  7. TRVmax

    Time frame: Baseline and 6h post-supine repositioning (T3)

    Maximal Tricuspid Regurgitation Velocity (m/s)

  8. LVEF

    Time frame: At baseline (T0) and at 6 hours after supine repositioning (T3)

    Left Ventricular Ejection Fraction（%）

  9. SV

    Time frame: Baseline and 6h post-supine repositioning (T3)

    Stroke Volume（ml）

  10. CO

    Time frame: Baseline and 6h post-supine repositioning (T3)

    Cardiac Output (L/min)

  11. 28-Day Mortality

    Time frame: At 28 days after enrollment

    All-cause mortality within 28 days after enrollment.

  12. Ventilator-Free Days at 28 Days

    Time frame: At 28 days after enrollment

    Number of days alive and free from invasive mechanical ventilation during the first 28 days after enrollment.

  13. ICU Length of Stay

    Time frame: From enrollment through ICU discharge, assessed up to 28 days

    Total duration of ICU stay (in days) from enrollment to ICU discharge or death.

  14. Incidence of ECMO Use

    Time frame: During the ICU stay, assessed up to 28 days

    Proportion of patients requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO) during the ICU stay.

  15. Incidence of Tracheostomy

    Time frame: During the ICU stay, assessed up to 28 days.

    Proportion of patients undergoing tracheostomy during the ICU stay.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianmin Ling, MD

CONTACT

[email protected]

Min Xie, MD, PhD

CONTACT

[email protected]

+86-27-83665204

Sponsors and collaborators

Lead sponsor

XIE MIN

Other

Registry information

Official study title

A Randomized Controlled Trial of Early EIT-Guided PEEP Titration on Pulmonary Physiology in Moderate-to-Severe ARDS Patients Undergoing Prone Positioning

Acronym: EIT-PEEP-PRONE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

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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