Early EIT-Guided PEEP Titration on Pulmonary Physiology in Patients With Moderate-to-Severe ARDS Undergoing Prone Positioning (EIT-PEEP-PRONE) (EIT-PEEP-PRONE)
2026년 8월 26일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
40
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Min Xie, MD, PhD
- 전화번호: +86-27-83665204
- 이메일: Xie_m@126.com
연구 연락처 백업
- 이름: Jianmin Ling, MD
- 이메일: 2018tj5179@hust.edu.cn
연구 장소
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Hubei
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Wuhan, Hubei, 중국, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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연락하다:
- Min Xie, MD, PhD
- 전화번호: +86-27-83665204
- 이메일: 2018tj5179@hust.edu.cn
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Ventilation-Perfusion (V/Q) Matching Percentage
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Respiratory System Compliance
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Min Xie, Tongji Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 8월 31일
기본 완료 (추정된)
기본 완료
2027년 5월 20일
연구 완료 (추정된)
연구 완료
2027년 6월 30일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 20일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 26일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 28일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 26일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- TJ-IRB202605019
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .