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

18 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

88

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: 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).
Experimenteel: PS-ZEEP SBT then T-piece SBT
In this arm, PS-ZEEP SBT will be evaluated first and T-piece SBT ina second time.
Procedure: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
E/e' ratio
Tijdsspanne: 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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Limoges

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

7 augustus 2029

Studie voltooiing (Geschat)

7 augustus 2029

Studieregistratiedata

Eerst ingediend

18 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 juni 2026

Eerst geplaatst (Werkelijk)

24 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

18 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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