Early EIT-Guided PEEP Titration on Pulmonary Physiology in Patients With Moderate-to-Severe ARDS Undergoing Prone Positioning (EIT-PEEP-PRONE) (EIT-PEEP-PRONE)
2026年8月26日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Min Xie, MD, PhD
- 电话号码：+86-27-83665204
- 邮箱：Xie_m@126.com
研究联系人备份
- 姓名：Jianmin Ling, MD
- 邮箱：2018tj5179@hust.edu.cn
学习地点
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Hubei
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Wuhan、Hubei、中国、430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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接触：
- Min Xie, MD, PhD
- 电话号码：+86-27-83665204
- 邮箱：2018tj5179@hust.edu.cn
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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有源比较器：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Ventilation-Perfusion (V/Q) Matching Percentage
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Respiratory System Compliance
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Min Xie、Tongji Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月31日
初级完成 (估计的)
2027年5月20日
研究完成 (估计的)
2027年6月30日
研究注册日期
首次提交
2026年8月20日
首先提交符合 QC 标准的
2026年8月26日
首次发布 (实际的)
2026年8月28日
研究记录更新
最后更新发布 (实际的)
2026年8月28日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.