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

18. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

88

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verfahren: 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).
Experimental: PS-ZEEP SBT then T-piece SBT
In this arm, PS-ZEEP SBT will be evaluated first and T-piece SBT ina second time.
Verfahren: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
E/e' ratio
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospital, Limoges

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

7. August 2029

Studienabschluss (Geschätzt)

7. August 2029

Studienanmeldedaten

Zuerst eingereicht

18. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Juni 2026

Zuerst gepostet (Tatsächlich)

24. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 87RI25_0075 (WAPITI 2)
  • 2026-A00509-42 (Andere Kennung: ID-RCB)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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