此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Hemodynamic Impact of the Spontaneous Ventilation Test in Patients at Risk of Weaning Pulmonary Oedema (WAPITI 2)

2026年6月18日更新者：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.

研究概览

地位

尚未招聘

条件

断奶引起的肺水肿

干预/治疗

研究类型

介入性

注册 (估计的)

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。

学习地点

法国
- - Boulogne-Billancourt、法国、92100
    - Ambroise Paré Hospital -APHP
    - 接触：
      
      Adrien JOSEPH, MD
      
      电话号码：0149095601
      
      邮箱：adrien.joseph@aphp.fr
    - 首席研究员：
      
      Adrien JOSEPH, MD
  - Limoges、法国、87042
    - Limoges University hospital
    - 首席研究员：
      
      Philippe VIGNON, MD
    - 接触：
      
      Philippe VIGNON, MD
      
      电话号码：+33 05 55 05 88 41
      
      邮箱：philippe.vignon@chu-limoges.fr
  - Nice、法国、06000
    - Nice University Hospital - Archet
    - 接触：
      
      Mathieu JOZWIAK, MD
      
      电话号码：+33 0492035510
      
      邮箱：jozwiak.m@chu-nice.fr
    - 首席研究员：
      
      Mathieu JOZWIAK, MD
  - Nice、法国、06000
    - Nice university hospital - Pasteur
    - 首席研究员：
      
      Denis DOYEN, MD
    - 接触：
      
      denis DOYEN, MD+33
      
      电话号码：0492033622
      
      邮箱：denis.doyen@chu-nice.fr

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:

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

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：预防
分配：随机化
介入模型：交叉作业
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：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.	程序：T-piece SBT 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).
实验性的：PS-ZEEP SBT then T-piece SBT In this arm, PS-ZEEP SBT will be evaluated first and T-piece SBT ina second time.	程序：PS-ZEEP SBT 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).

参与者组/臂

干预/治疗

实验性的：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.

程序：T-piece SBT

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).

实验性的：PS-ZEEP SBT then T-piece SBT

In this arm, PS-ZEEP SBT will be evaluated first and T-piece SBT ina second time.

程序：PS-ZEEP SBT

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).

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
E/e' ratio 大体时间：Day 1	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)	Day 1

次要结果测量

结果测量	措施说明	大体时间
Absolute change in the averaged E/e' ratio 大体时间：Day1	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	Day1
Absolute change in arterial pressure 大体时间：day 1	The absolute change in arterial pressure between the baseline period and the end of the SBT	day 1
Relative change in arterial pressure 大体时间：Day 1	The relative change in arterial pressure between the baseline period and the end of the SBT	Day 1
Number of WIPE cases 大体时间：Day 1	The number of WIPE cases	Day 1
Proportion of WIPE cases 大体时间：Day 1	The proportion of WIPE cases	Day 1
Number of SBT interruptions 大体时间：Day 1	The number of SBT interruptions related to WIPE	Day 1
Absolute change in peak velocity of the mitral E wave 大体时间：Day 1	The absolute change in the peak velocity of the mitral E wave at the lateral and septal mitral annulus	Day 1
Relative change in peak velocity of the mitral E wave 大体时间：Day 1	The relative change in the peak velocity of the mitral E wave at the lateral and septal mitral annulus	Day 1
Relative change in peak velocity of the mitral e' wave 大体时间：Day 1	The relative change in the peak velocity of the mitral e' wave at the lateral and septal mitral annulus	Day 1
Absolute change in peak velocity of the mitral e' wave 大体时间：Day 1	The absolute change in the peak velocity of the mitral e' wave at the lateral and septal mitral annulus	Day 1
Absolute change in peak velocity of tricuspid regurgitation 大体时间：Day 1	The absolute change in the peak velocity of tricuspid regurgitation	Day 1
Relative change in peak velocity of tricuspid regurgitation 大体时间：Day 1	The relative change in the peak velocity of tricuspid regurgitation	Day 1
Number of clinically relevant mitral regurgitation 大体时间：Day 1	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	Day 1
Proportion of clinically relevant mitral regurgitation 大体时间：Day 1	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	Day 1
Semi-quantitative assessment of clinically relevant mitral regurgitation 大体时间：Day 1	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	Day 1
Number of dynamic left ventricular outflow tract obstruction 大体时间：Day 1	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	Day 1
Proportion of dynamic left ventricular outflow tract obstruction 大体时间：Day 1	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	Day 1
Semi-quantitative assessment of dynamic left ventricular outflow tract obstruction 大体时间：Day 1	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	Day 1
Lung ultrasound aeration score 大体时间：Day 1	The lung ultrasound aeration score (0 to 3) across all 12 quadrants between the baseline period and the end of the SBT	Day 1
The number of SBTs performed 大体时间：Day 1	The number of SBTs performed before extubation	Day 1
The type of SBTs performed 大体时间：Day 1	The type of SBTs performed before extubation	Day 1
Duration of such ventilatory support 大体时间：Day 1	The Duration of such ventilatory support	Day 1
Number of patients requiring ventilatory support 大体时间：Day 1	The number of patients requiring ventilatory support with high-flow oxygen therapy (e.g., Optiflow©) or non-invasive ventilation	Day 1
Number of patients requiring reintubation for mechanical ventilation 大体时间：Day 7	The number of patients requiring reintubation for mechanical ventilation within the week following extubation (extubation failure); the day of reintubation, where applicable	Day 7
The number of hours between the second SBT and extubation 大体时间：Day 1	The number of hours between the second SBT and extubation	Day 1
Description of the therapeutic changes 大体时间：Day 1	A description of the therapeutic changes introduced after the second SBT and before extubation	Day 1
Relative change in hematocrit 大体时间：Day 1	The relative change in hematocrit, between the baseline period and the end of the SBT	Day 1
Absolute change in NT-pro-BNP 大体时间：Day 1	The absolute change in NT-pro-BNP, between the baseline period and the end of the SBT	Day 1
Absolute change in hematocrit 大体时间：Day 1	The absolute change in hematocrit, between the baseline period and the end of the SBT	Day 1
Relative change in NT-pro-BNP 大体时间：Day 1	The relative change in NT-pro-BNP, between the baseline period and the end of the SBT	Day 1
Relative change in total plasma protein levels 大体时间：Day 1	The relative change in total plasma protein levels, between the baseline period and the end of the SBT	Day 1
Absolute change in total plasma protein levels 大体时间：Day 1	The absolute change in total plasma protein levels, between the baseline period and the end of the SBT	Day 1

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

University Hospital, Limoges

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1日

初级完成 (估计的)

2029年8月7日

研究完成 (估计的)

2029年8月7日

研究注册日期

首次提交

2026年6月18日

首先提交符合 QC 标准的

2026年6月18日

首次发布 (实际的)

2026年6月24日

研究记录更新

最后更新发布 (实际的)

2026年6月24日

上次提交的符合 QC 标准的更新

2026年6月18日

最后验证

2026年6月1日

Hemodynamic Impact of the Spontaneous Ventilation Test in Patients at Risk of Weaning Pulmonary Oedema (WAPITI 2)

研究概览

地位

条件

干预/治疗

研究类型

注册 (估计的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

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

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

研究记录日期

研究主要日期

学习开始 (估计的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

关键字

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品