Hemodynamic Impact of the Spontaneous Ventilation Test in Patients at Risk of Weaning Pulmonary Oedema (WAPITI 2)
2026년 6월 18일 업데이트: University Hospital, Limoges
Weaning-induced pulmonary edema (WIPE) from the ventilator is a frequent cause of extubation failure or delay, which prolongs the duration of invasive mechanical ventilation and the associated morbidity and mortality. WIPE is a very frequent cause of extubation failure in at-risk patients. A spontaneous breathing trial (SBT) is performed before extubating a patient, either by disconnecting the patient from the ventilator (T-piece SBT) or by setting the ventilator to spontaneous breathing mode with pressure support at 7 cm H2O and zero positive end-expiratory pressure (PS-ZEEP SBT). There is currently no recommendation regarding which SBT modality should be used, particularly in patients at risk of WIPE. The hemodynamic changes induced by the SBT can lead to WIPE, which typically develops within minutes of the SBT onset.
The hypothesis being tested is that, by altering intrathoracic pressure during the patient's inspiration (negative pressure), the T-piece SBT leads to a greater increase in left ventricular filling pressures compared to the PS-ZEEP SBT.
연구 개요
연구 유형
중재적
등록 (추정된)
88
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Boulogne-Billancourt, 프랑스, 92100
- Ambroise Paré Hospital -APHP
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연락하다:
- Adrien JOSEPH, MD
- 전화번호: 0149095601
- 이메일: adrien.joseph@aphp.fr
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수석 연구원:
- Adrien JOSEPH, MD
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Limoges, 프랑스, 87042
- Limoges University hospital
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수석 연구원:
- Philippe VIGNON, MD
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연락하다:
- Philippe VIGNON, MD
- 전화번호: +33 05 55 05 88 41
- 이메일: philippe.vignon@chu-limoges.fr
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Nice, 프랑스, 06000
- Nice University Hospital - Archet
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연락하다:
- Mathieu JOZWIAK, MD
- 전화번호: +33 0492035510
- 이메일: jozwiak.m@chu-nice.fr
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수석 연구원:
- Mathieu JOZWIAK, MD
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Nice, 프랑스, 06000
- Nice university hospital - Pasteur
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수석 연구원:
- Denis DOYEN, MD
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연락하다:
- denis DOYEN, MD+33
- 전화번호: 0492033622
- 이메일: denis.doyen@chu-nice.fr
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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
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Adult patient (> 18 years) on invasive mechanical ventilation in the ICU for more than 48 hours
- In the ventilator weaning phase with a first SBT planned
- At risk of WIPE: age over 65 years and/or any type of heart disease and/or chronic respiratory failure and/or obesity
Exclusion Criteria:
- Patient who has already participated in the study
- No transthoracic echocardiographic images suitable for analysis
- Non-sinus rhythm (including pacemaker)
- Tracheostomy
- Chronic neuromuscular or neurodegenerative disease
- Persons deprived of liberty or under legal protection
- Pregnant or breastfeeding woman
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: T-piece SBT then PS-ZEEP SBT
In this arm, T-piece SBT will be evaluated first and PS-ZEEP SBT in a second time.
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T-piece SBT will be evaluated first and PS-ZEEP SBT in a second time.
If the first SBT fails, regardless of the modality used or the cause of failure, the second SBT will not be performed.
The patient will then be managed according to the participating centers' standard of care (treatment guided by the main mechanism of WIPE identified by echocardiography).
The two SBTs will be separated by at least 6 hours, during which no therapeutic changes will be made (in case of success at the first SBT).
This interval corresponds to the usual SBT schedule (typically one SBT in the morning and one in the afternoon).
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실험적: PS-ZEEP SBT then T-piece SBT
In this arm, PS-ZEEP SBT will be evaluated first and T-piece SBT ina second time.
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In this arm, PS-ZEEP SBT will be evaluated first and T-piece SBT ina second time.
If the first SBT fails, regardless of the modality used or the cause of failure, the second SBT will not be performed.
The patient will then be managed according to the participating centers' standard of care (treatment guided by the main mechanism of WIPE identified by echocardiography).
The two SBTs will be separated by at least 6 hours, during which no therapeutic changes will be made (in case of success at the first SBT).
This interval corresponds to the usual SBT schedule (typically one SBT in the morning and one in the afternoon).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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E/e' ratio
기간: Day 1
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Difference in the percentage change in the averaged E/e' ratio (reflecting changes in left ventricular filling pressures) between the baseline period (just before the start of the SBT) and the end of the SBT (30 minutes if successful, or at the onset of WIPE, whichever occurs first)
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Day 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Absolute change in the averaged E/e' ratio
기간: Day1
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Comparison between patients according to the modality of the first SBT (T-piece SBT vs. PS-ZEEP SBT) of the absolute change in the averaged E/e' ratio between the baseline period and the end of the SBT
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Day1
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Absolute change in arterial pressure
기간: day 1
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The absolute change in arterial pressure between the baseline period and the end of the SBT
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day 1
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Relative change in arterial pressure
기간: Day 1
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The relative change in arterial pressure between the baseline period and the end of the SBT
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Day 1
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Number of WIPE cases
기간: Day 1
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The number of WIPE cases
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Day 1
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Proportion of WIPE cases
기간: Day 1
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The proportion of WIPE cases
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Day 1
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Number of SBT interruptions
기간: Day 1
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The number of SBT interruptions related to WIPE
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Day 1
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Absolute change in peak velocity of the mitral E wave
기간: Day 1
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The absolute change in the peak velocity of the mitral E wave at the lateral and septal mitral annulus
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Day 1
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Relative change in peak velocity of the mitral E wave
기간: Day 1
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The relative change in the peak velocity of the mitral E wave at the lateral and septal mitral annulus
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Day 1
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Relative change in peak velocity of the mitral e' wave
기간: Day 1
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The relative change in the peak velocity of the mitral e' wave at the lateral and septal mitral annulus
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Day 1
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Absolute change in peak velocity of the mitral e' wave
기간: Day 1
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The absolute change in the peak velocity of the mitral e' wave at the lateral and septal mitral annulus
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Day 1
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Absolute change in peak velocity of tricuspid regurgitation
기간: Day 1
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The absolute change in the peak velocity of tricuspid regurgitation
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Day 1
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Relative change in peak velocity of tricuspid regurgitation
기간: Day 1
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The relative change in the peak velocity of tricuspid regurgitation
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Day 1
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Number of clinically relevant mitral regurgitation
기간: Day 1
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The number (regurgitant jet area ratio on color Doppler with a maximal Nyquist limit, relative to left atrial area) of clinically relevant mitral regurgitation (≥ grade 2) between the baseline period and the end of the SBT
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Day 1
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Proportion of clinically relevant mitral regurgitation
기간: Day 1
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The proportion (regurgitant jet area ratio on color Doppler with a maximal Nyquist limit, relative to left atrial area) of clinically relevant mitral regurgitation (≥ grade 2) between the baseline period and the end of the SBT
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Day 1
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Semi-quantitative assessment of clinically relevant mitral regurgitation
기간: Day 1
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The semi-quantitative assessment (regurgitant jet area ratio on color Doppler with a maximal Nyquist limit, relative to left atrial area) of clinically relevant mitral regurgitation (≥ grade 2) between the baseline period and the end of the SBT
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Day 1
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Number of dynamic left ventricular outflow tract obstruction
기간: Day 1
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The number (measurement of the maximal systolic gradient on continuous-wave Doppler) of dynamic left ventricular outflow tract obstruction between the baseline period and the end of the SBT
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Day 1
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Proportion of dynamic left ventricular outflow tract obstruction
기간: Day 1
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The proportion The number (measurement of the maximal systolic gradient on continuous-wave Doppler) of dynamic left ventricular outflow tract obstruction between the baseline period and the end of the SBT
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Day 1
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Semi-quantitative assessment of dynamic left ventricular outflow tract obstruction
기간: Day 1
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The semi-quantitative assessment (measurement of the maximal systolic gradient on continuous-wave Doppler) of dynamic left ventricular outflow tract obstruction between the baseline period and the end of the SBT
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Day 1
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Lung ultrasound aeration score
기간: Day 1
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The lung ultrasound aeration score (0 to 3) across all 12 quadrants between the baseline period and the end of the SBT
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Day 1
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The number of SBTs performed
기간: Day 1
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The number of SBTs performed before extubation
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Day 1
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The type of SBTs performed
기간: Day 1
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The type of SBTs performed before extubation
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Day 1
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Duration of such ventilatory support
기간: Day 1
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The Duration of such ventilatory support
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Day 1
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Number of patients requiring ventilatory support
기간: Day 1
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The number of patients requiring ventilatory support with high-flow oxygen therapy (e.g., Optiflow©) or non-invasive ventilation
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Day 1
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Number of patients requiring reintubation for mechanical ventilation
기간: Day 7
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The number of patients requiring reintubation for mechanical ventilation within the week following extubation (extubation failure); the day of reintubation, where applicable
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Day 7
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The number of hours between the second SBT and extubation
기간: Day 1
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The number of hours between the second SBT and extubation
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Day 1
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Description of the therapeutic changes
기간: Day 1
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A description of the therapeutic changes introduced after the second SBT and before extubation
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Day 1
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Relative change in hematocrit
기간: Day 1
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The relative change in hematocrit, between the baseline period and the end of the SBT
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Day 1
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Absolute change in NT-pro-BNP
기간: Day 1
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The absolute change in NT-pro-BNP, between the baseline period and the end of the SBT
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Day 1
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Absolute change in hematocrit
기간: Day 1
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The absolute change in hematocrit, between the baseline period and the end of the SBT
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Day 1
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Relative change in NT-pro-BNP
기간: Day 1
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The relative change in NT-pro-BNP, between the baseline period and the end of the SBT
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Day 1
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Relative change in total plasma protein levels
기간: Day 1
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The relative change in total plasma protein levels, between the baseline period and the end of the SBT
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Day 1
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Absolute change in total plasma protein levels
기간: Day 1
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The absolute change in total plasma protein levels, between the baseline period and the end of the SBT
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Day 1
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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)
2026년 8월 1일
기본 완료 (추정된)
2029년 8월 7일
연구 완료 (추정된)
2029년 8월 7일
연구 등록 날짜
최초 제출
2026년 6월 18일
QC 기준을 충족하는 최초 제출
2026년 6월 18일
처음 게시됨 (실제)
2026년 6월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 18일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 87RI25_0075 (WAPITI 2)
- 2026-A00509-42 (기타 식별자: ID-RCB)
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. .