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

18. juni 2026 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

88

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: 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).
Eksperimentell: PS-ZEEP SBT then T-piece SBT
In this arm, PS-ZEEP SBT will be evaluated first and T-piece SBT ina second time.
Fremgangsmåte: 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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
E/e' ratio
Tidsramme: 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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Limoges

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

7. august 2029

Studiet fullført (Antatt)

7. august 2029

Datoer for studieregistrering

Først innsendt

18. juni 2026

Først innsendt som oppfylte QC-kriteriene

18. juni 2026

Først lagt ut (Faktiske)

24. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 87RI25_0075 (WAPITI 2)
  • 2026-A00509-42 (Annen identifikator: ID-RCB)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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