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.
調査の概要
研究の種類
介入
入学 (推定)
88
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。
研究場所
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Boulogne-Billancourt、フランス、92100
- Ambroise Paré Hospital -APHP
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コンタクト：
- Adrien JOSEPH, MD
- 電話番号：0149095601
- メール：adrien.joseph@aphp.fr
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主任研究者：
- Adrien JOSEPH, MD
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Limoges、フランス、87042
- Limoges University hospital
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主任研究者：
- Philippe VIGNON, MD
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コンタクト：
- Philippe VIGNON, MD
- 電話番号：+33 05 55 05 88 41
- メール：philippe.vignon@chu-limoges.fr
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Nice、フランス、06000
- Nice University Hospital - Archet
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コンタクト：
- Mathieu JOZWIAK, MD
- 電話番号：+33 0492035510
- メール：jozwiak.m@chu-nice.fr
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主任研究者：
- Mathieu JOZWIAK, MD
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Nice、フランス、06000
- Nice university hospital - Pasteur
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主任研究者：
- Denis DOYEN, MD
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コンタクト：
- denis DOYEN, MD+33
- 電話番号：0492033622
- メール：denis.doyen@chu-nice.fr
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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:
- 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
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：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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：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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実験的：PS-ZEEP SBT then T-piece SBT
In this arm, PS-ZEEP SBT will be evaluated first and T-piece SBT ina second time.
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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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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 |
|---|---|---|
|
E/e' ratio
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Absolute change in the averaged E/e' ratio
時間枠：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
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Day1
|
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Absolute change in arterial pressure
時間枠：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
時間枠：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
時間枠：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
時間枠：Day 1
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The proportion of WIPE cases
|
Day 1
|
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Number of SBT interruptions
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Day 1
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The absolute change in the peak velocity of tricuspid regurgitation
|
Day 1
|
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Relative change in peak velocity of tricuspid regurgitation
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
Day 1
|
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Lung ultrasound aeration score
時間枠：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
|
Day 1
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The number of SBTs performed
時間枠：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
時間枠：Day 1
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The type of SBTs performed before extubation
|
Day 1
|
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Duration of such ventilatory support
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Day 1
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The relative change in hematocrit, between the baseline period and the end of the SBT
|
Day 1
|
|
Absolute change in NT-pro-BNP
時間枠：Day 1
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The absolute change in NT-pro-BNP, between the baseline period and the end of the SBT
|
Day 1
|
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Absolute change in hematocrit
時間枠：Day 1
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The absolute change in hematocrit, between the baseline period and the end of the SBT
|
Day 1
|
|
Relative change in NT-pro-BNP
時間枠：Day 1
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The relative change in NT-pro-BNP, between the baseline period and the end of the SBT
|
Day 1
|
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Relative change in total plasma protein levels
時間枠：Day 1
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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
時間枠：Day 1
|
The absolute change in total plasma protein levels, between the baseline period and the end of the SBT
|
Day 1
|
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。
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1日
一次修了 (推定)
2029年8月7日
研究の完了 (推定)
2029年8月7日
試験登録日
最初に提出
2026年6月18日
QC基準を満たした最初の提出物
2026年6月18日
最初の投稿 (実際)
2026年6月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月24日
QC基準を満たした最後の更新が送信されました
2026年6月18日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 87RI25_0075 (WAPITI 2)
- 2026-A00509-42 (その他の識別子：ID-RCB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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いいえ
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いいえ
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