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

NCT07793565 | Not Yet Recruiting

• 1 other identifier: TJ-IRB202605019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

• Ventilation-Perfusion (V/Q) Matching Percentage

  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.

  At 18 hours of prone positioning (T2) and at 6 hours after supine repositioning (T3)

Secondary Outcomes (15)

• Respiratory System Compliance

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

• Driving Pressure

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

• EIT-Derived Regional Ventilation Distribution

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

• RVEDA/LVEDA

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

• RVFAC

  Baseline and 6h post-supine repositioning (T3)

Study Arms (2)

EIT-Guided PEEP Titration Group

EXPERIMENTAL

PEEP will be titrated using EIT monitoring at 4 hours after prone positioning initiation (T1). The optimal PEEP will be determined at the intersection of the cumulative collapse and overdistension curves, or at the lowest global inhomogeneity index if the intersection occurs between two PEEP levels.

Other: EIT-Guided PEEP Titration Group

ARDSNet/PEEP-FiO₂ Table Group

ACTIVE COMPARATOR

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

Other: ARDSNet/PEEP-FiO₂ Table

Interventions

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.

EIT-Guided PEEP Titration Group

ARDSNet/PEEP-FiO₂ Table OTHER

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

ARDSNet/PEEP-FiO₂ Table Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• XIE MIN: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Related Publications (9)

• Sang L, Lin Z, Zhao Z. How often do we need to update PEEP setting during prone positioning in ARDS? Crit Care. 2024 Feb 26;28(1):60. doi: 10.1186/s13054-024-04847-w. No abstract available.

  PMID: 38409024 BACKGROUND

• Servetti A, Battaglini D, Patroniti NA, Al Sharie S, Jouryyeh B, Al-Husinat L, Marini JJ, Rocco PRM. Optimising positive end-expiratory pressure in acute respiratory distress syndrome: a narrative review of approaches to titration. Br J Anaesth. 2026 May;136(5):1472-1481. doi: 10.1016/j.bja.2025.12.048. Epub 2026 Jan 27.

  PMID: 41592990 BACKGROUND

• Cornejo R, Papazian L, Martin Delgado MC. Physiological effects of prone positioning during invasive mechanical ventilation: beyond PaO2. Intensive Care Med. 2026 Mar;52(3):574-577. doi: 10.1007/s00134-026-08305-9. Epub 2026 Feb 9. No abstract available.

  PMID: 41661291 BACKGROUND

• Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

  PMID: 23688302 BACKGROUND

• Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

  PMID: 26903337 BACKGROUND

• Al-Husinat L, Azzam S, Al Sharie S, Araydah M, Battaglini D, Abushehab S, Cortes-Puentes GA, Schultz MJ, Rocco PRM. A narrative review on the future of ARDS: evolving definitions, pathophysiology, and tailored management. Crit Care. 2025 Feb 24;29(1):88. doi: 10.1186/s13054-025-05291-0.

  PMID: 39994815 BACKGROUND

• Wang R, Wang W, Tang X, Qi Z, Li T, Liu Y, Li H, Yan J, Yang H, Lyu W, Li Z, Sun B, Gan G. Association between ventilation-perfusion matching improvement during initial prone positioning and ICU mortality in patients with moderate to severe ARDS: a prospective two-center study. Ann Intensive Care. 2025 May 21;15(1):69. doi: 10.1186/s13613-025-01489-1.

  PMID: 40394400 RESULT

• Songsangvorn N, Xu Y, Lu C, Rotstein O, Brochard L, Slutsky AS, Burns KEA, Zhang H. Electrical impedance tomography-guided positive end-expiratory pressure titration in ARDS: a systematic review and meta-analysis. Intensive Care Med. 2024 May;50(5):617-631. doi: 10.1007/s00134-024-07362-2. Epub 2024 Mar 21.

  PMID: 38512400 RESULT

• He H, Zhao Z, Becher T, Bellani G, Yoshida T, Amato MBP, Long Y, Frerichs I; REspiratory and Critical Care medicine EIT study (RECCE) group. Recommendations for lung ventilation and perfusion assessment with chest electrical impedance tomography in critically ill adult patients: an international evidence-based and expert Delphi consensus study. EClinicalMedicine. 2025 Oct 17;89:103575. doi: 10.1016/j.eclinm.2025.103575. eCollection 2025 Nov.

  PMID: 41158153 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Min Xie

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Xie, MD, PhD

CONTACT

+86-27-83665204; Xie_m@126.com

Jianmin Ling, MD

CONTACT

2018tj5179@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Department of Intensive Care Unit

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 28, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)