Early EIT-Guided PEEP Titration on Pulmonary Physiology in Patients With Moderate-to-Severe ARDS Undergoing Prone Positioning (EIT-PEEP-PRONE) (EIT-PEEP-PRONE)
26 augustus 2026 bijgewerkt door: XIE MIN
A Randomized Controlled Trial of Early EIT-Guided PEEP Titration on Pulmonary Physiology in Moderate-to-Severe ARDS Patients Undergoing Prone Positioning
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Min Xie, MD, PhD
- Telefoonnummer: +86-27-83665204
- E-mail: Xie_m@126.com
Studie Contact Back-up
- Naam: Jianmin Ling, MD
- E-mail: 2018tj5179@hust.edu.cn
Studie Locaties
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Hubei
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Wuhan, Hubei, China, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Contact:
- Min Xie, MD, PhD
- Telefoonnummer: +86-27-83665204
- E-mail: 2018tj5179@hust.edu.cn
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: EIT-Guided PEEP Titration Group
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.
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PEEP titration is performed during mechanical ventilation to optimize respiratory mechanics and ventilation-perfusion matching in patients with ARDS.
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Actieve vergelijker: ARDSNet/PEEP-FiO₂ Table Group
PEEP will be set according to the ARDSNet/PEEP-FiO₂ table at 4 hours after prone positioning initiation (T1).
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PEEP will be set according to the ARDSNet/PEEP-FiO₂ table at 4 hours after prone positioning initiation (T1).
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Ventilation-Perfusion (V/Q) Matching Percentage
Tijdsspanne: At 18 hours of prone positioning (T2) and at 6 hours after supine repositioning (T3)
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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.
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At 18 hours of prone positioning (T2) and at 6 hours after supine repositioning (T3)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Respiratory System Compliance
Tijdsspanne: Baseline, T2 (18h prone), and T3 (6h post-supine)
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Respiratory system compliance (Crs) calculated as tidal volume divided by driving pressure (plateau pressure minus PEEP), measured under volume-controlled ventilation.
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Baseline, T2 (18h prone), and T3 (6h post-supine)
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Driving Pressure
Tijdsspanne: At baseline (T0), at 18 hours of prone positioning (T2), and at 6 hours after supine repositioning (T3)
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Driving pressure (DP) calculated as plateau pressure (Pplat) minus PEEP, measured under volume-controlled ventilation.
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At baseline (T0), at 18 hours of prone positioning (T2), and at 6 hours after supine repositioning (T3)
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EIT-Derived Regional Ventilation Distribution
Tijdsspanne: At baseline (T0), at 18 hours of prone positioning (T2), and at 6 hours after supine repositioning (T3)
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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.
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At baseline (T0), at 18 hours of prone positioning (T2), and at 6 hours after supine repositioning (T3)
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RVEDA/LVEDA
Tijdsspanne: At baseline (T0) and at 6 hours after supine repositioning (T3)
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Right Ventricular End-Diastolic Area to Left Ventricular End-Diastolic Area Ratio
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At baseline (T0) and at 6 hours after supine repositioning (T3)
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RVFAC
Tijdsspanne: Baseline and 6h post-supine repositioning (T3)
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Right Ventricular Fractional Area Change（%）
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Baseline and 6h post-supine repositioning (T3)
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TAPSE
Tijdsspanne: Baseline and 6h post-supine repositioning (T3)
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Tricuspid Annular Plane Systolic Excursion (mm)
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Baseline and 6h post-supine repositioning (T3)
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TRVmax
Tijdsspanne: Baseline and 6h post-supine repositioning (T3)
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Maximal Tricuspid Regurgitation Velocity (m/s)
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Baseline and 6h post-supine repositioning (T3)
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LVEF
Tijdsspanne: At baseline (T0) and at 6 hours after supine repositioning (T3)
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Left Ventricular Ejection Fraction（%）
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At baseline (T0) and at 6 hours after supine repositioning (T3)
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SV
Tijdsspanne: Baseline and 6h post-supine repositioning (T3)
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Stroke Volume（ml）
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Baseline and 6h post-supine repositioning (T3)
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CO
Tijdsspanne: Baseline and 6h post-supine repositioning (T3)
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Cardiac Output (L/min)
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Baseline and 6h post-supine repositioning (T3)
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28-Day Mortality
Tijdsspanne: At 28 days after enrollment
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All-cause mortality within 28 days after enrollment.
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At 28 days after enrollment
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Ventilator-Free Days at 28 Days
Tijdsspanne: At 28 days after enrollment
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Number of days alive and free from invasive mechanical ventilation during the first 28 days after enrollment.
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At 28 days after enrollment
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ICU Length of Stay
Tijdsspanne: From enrollment through ICU discharge, assessed up to 28 days
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Total duration of ICU stay (in days) from enrollment to ICU discharge or death.
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From enrollment through ICU discharge, assessed up to 28 days
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Incidence of ECMO Use
Tijdsspanne: During the ICU stay, assessed up to 28 days
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Proportion of patients requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO) during the ICU stay.
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During the ICU stay, assessed up to 28 days
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Incidence of Tracheostomy
Tijdsspanne: During the ICU stay, assessed up to 28 days.
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Proportion of patients undergoing tracheostomy during the ICU stay.
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During the ICU stay, assessed up to 28 days.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Min Xie, Tongji Hospital
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
31 augustus 2026
Primaire voltooiing (Geschat)
20 mei 2027
Studie voltooiing (Geschat)
30 juni 2027
Studieregistratiedata
Eerst ingediend
20 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
26 augustus 2026
Eerst geplaatst (Werkelijk)
28 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
28 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
26 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TJ-IRB202605019
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NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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