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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Min Xie, MD, PhD
- 電話番号：+86-27-83665204
- メール：Xie_m@126.com
研究連絡先のバックアップ
- 名前：Jianmin Ling, MD
- メール：2018tj5179@hust.edu.cn
研究場所
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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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コンタクト：
- Min Xie, MD, PhD
- 電話番号：+86-27-83665204
- メール：2018tj5179@hust.edu.cn
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Ventilation-Perfusion (V/Q) Matching Percentage
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Respiratory System Compliance
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Min Xie、Tongji Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月31日
一次修了 (推定)
2027年5月20日
研究の完了 (推定)
2027年6月30日
試験登録日
最初に提出
2026年8月20日
QC基準を満たした最初の提出物
2026年8月26日
最初の投稿 (実際)
2026年8月28日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月28日
QC基準を満たした最後の更新が送信されました
2026年8月26日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。