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

18 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

88

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Procedur: 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).
Experimentell: PS-ZEEP SBT then T-piece SBT
In this arm, PS-ZEEP SBT will be evaluated first and T-piece SBT ina second time.
Procedur: 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).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
E/e' ratio
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Limoges

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

7 augusti 2029

Avslutad studie (Beräknad)

7 augusti 2029

Studieregistreringsdatum

Först inskickad

18 juni 2026

Först inskickad som uppfyllde QC-kriterierna

18 juni 2026

Första postat (Faktisk)

24 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 87RI25_0075 (WAPITI 2)
  • 2026-A00509-42 (Annan identifierare: ID-RCB)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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