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 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Min Xie, MD, PhD
- Número de telefone: +86-27-83665204
- E-mail: Xie_m@126.com
Estude backup de contato
- Nome: Jianmin Ling, MD
- E-mail: 2018tj5179@hust.edu.cn
Locais de estudo
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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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Contato:
- Min Xie, MD, PhD
- Número de telefone: +86-27-83665204
- E-mail: 2018tj5179@hust.edu.cn
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Ventilation-Perfusion (V/Q) Matching Percentage
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Respiratory System Compliance
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Min Xie, Tongji Hospital
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
31 de agosto de 2026
Conclusão Primária (Estimado)
20 de maio de 2027
Conclusão do estudo (Estimado)
30 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
20 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de agosto de 2026
Primeira postagem (Real)
28 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TJ-IRB202605019
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
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