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

18 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

88

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • France
      • Boulogne-Billancourt, France, 92100
        • Ambroise Paré Hospital -APHP
        • Contact:
        • Chercheur principal:
          • Adrien JOSEPH, MD
      • Limoges, France, 87042
        • Limoges University hospital
        • Chercheur principal:
          • Philippe VIGNON, MD
        • Contact:
      • Nice, France, 06000
        • Nice University Hospital - Archet
        • Contact:
        • Chercheur principal:
          • Mathieu JOZWIAK, MD
      • Nice, France, 06000
        • Nice university hospital - Pasteur
        • Chercheur principal:
          • Denis DOYEN, MD
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Procédure: 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).
Expérimental: PS-ZEEP SBT then T-piece SBT
In this arm, PS-ZEEP SBT will be evaluated first and T-piece SBT ina second time.
Procédure: 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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
E/e' ratio
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Absolute change in the averaged E/e' ratio
Délai: 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
Délai: 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
Délai: Day 1
The relative change in arterial pressure between the baseline period and the end of the SBT
Day 1
Number of WIPE cases
Délai: Day 1
The number of WIPE cases
Day 1
Proportion of WIPE cases
Délai: Day 1
The proportion of WIPE cases
Day 1
Number of SBT interruptions
Délai: Day 1
The number of SBT interruptions related to WIPE
Day 1
Absolute change in peak velocity of the mitral E wave
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Day 1
The absolute change in the peak velocity of tricuspid regurgitation
Day 1
Relative change in peak velocity of tricuspid regurgitation
Délai: Day 1
The relative change in the peak velocity of tricuspid regurgitation
Day 1
Number of clinically relevant mitral regurgitation
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Day 1
The number of SBTs performed before extubation
Day 1
The type of SBTs performed
Délai: Day 1
The type of SBTs performed before extubation
Day 1
Duration of such ventilatory support
Délai: Day 1
The Duration of such ventilatory support
Day 1
Number of patients requiring ventilatory support
Délai: 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
Délai: 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
Délai: Day 1
The number of hours between the second SBT and extubation
Day 1
Description of the therapeutic changes
Délai: Day 1
A description of the therapeutic changes introduced after the second SBT and before extubation
Day 1
Relative change in hematocrit
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Day 1
The absolute change in total plasma protein levels, between the baseline period and the end of the SBT
Day 1

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Hospital, Limoges

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

7 août 2029

Achèvement de l'étude (Estimé)

7 août 2029

Dates d'inscription aux études

Première soumission

18 juin 2026

Première soumission répondant aux critères de contrôle qualité

18 juin 2026

Première publication (Réel)

24 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 87RI25_0075 (WAPITI 2)
  • 2026-A00509-42 (Autre identifiant: ID-RCB)

Plan pour les données individuelles des participants (IPD)

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Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

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