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NCT Number: NCT07666880

Hemodynamic Impact of the Spontaneous Ventilation Test in Patients at Risk of Weaning Pulmonary Oedema

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.

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Key information

Conditions

Weaning-induced Pulmonary Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ambroise Paré Hospital -APHP, Boulogne-Billancourt, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-piece SBT

Procedure

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).

PS-ZEEP SBT

Procedure

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).

Primary outcomes

  1. E/e' ratio

    Time frame: 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)

Secondary outcomes

  1. Absolute change in the averaged E/e' ratio

    Time frame: 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

  2. Absolute change in arterial pressure

    Time frame: day 1

    The absolute change in arterial pressure between the baseline period and the end of the SBT

  3. Relative change in arterial pressure

    Time frame: Day 1

    The relative change in arterial pressure between the baseline period and the end of the SBT

  4. Number of WIPE cases

    Time frame: Day 1

    The number of WIPE cases

  5. Proportion of WIPE cases

    Time frame: Day 1

    The proportion of WIPE cases

  6. Number of SBT interruptions

    Time frame: Day 1

    The number of SBT interruptions related to WIPE

  7. Absolute change in peak velocity of the mitral E wave

    Time frame: Day 1

    The absolute change in the peak velocity of the mitral E wave at the lateral and septal mitral annulus

  8. Relative change in peak velocity of the mitral E wave

    Time frame: Day 1

    The relative change in the peak velocity of the mitral E wave at the lateral and septal mitral annulus

  9. Relative change in peak velocity of the mitral e' wave

    Time frame: Day 1

    The relative change in the peak velocity of the mitral e' wave at the lateral and septal mitral annulus

  10. Absolute change in peak velocity of the mitral e' wave

    Time frame: Day 1

    The absolute change in the peak velocity of the mitral e' wave at the lateral and septal mitral annulus

  11. Absolute change in peak velocity of tricuspid regurgitation

    Time frame: Day 1

    The absolute change in the peak velocity of tricuspid regurgitation

  12. Relative change in peak velocity of tricuspid regurgitation

    Time frame: Day 1

    The relative change in the peak velocity of tricuspid regurgitation

  13. Number of clinically relevant mitral regurgitation

    Time frame: 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

  14. Proportion of clinically relevant mitral regurgitation

    Time frame: 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

  15. Semi-quantitative assessment of clinically relevant mitral regurgitation

    Time frame: 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

  16. Number of dynamic left ventricular outflow tract obstruction

    Time frame: 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

  17. Proportion of dynamic left ventricular outflow tract obstruction

    Time frame: 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

  18. Semi-quantitative assessment of dynamic left ventricular outflow tract obstruction

    Time frame: 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

  19. Lung ultrasound aeration score

    Time frame: Day 1

    The lung ultrasound aeration score (0 to 3) across all 12 quadrants between the baseline period and the end of the SBT

  20. The number of SBTs performed

    Time frame: Day 1

    The number of SBTs performed before extubation

  21. The type of SBTs performed

    Time frame: Day 1

    The type of SBTs performed before extubation

  22. Duration of such ventilatory support

    Time frame: Day 1

    The Duration of such ventilatory support

  23. Number of patients requiring ventilatory support

    Time frame: Day 1

    The number of patients requiring ventilatory support with high-flow oxygen therapy (e.g., Optiflow©) or non-invasive ventilation

  24. Number of patients requiring reintubation for mechanical ventilation

    Time frame: Day 7

    The number of patients requiring reintubation for mechanical ventilation within the week following extubation (extubation failure); the day of reintubation, where applicable

  25. The number of hours between the second SBT and extubation

    Time frame: Day 1

    The number of hours between the second SBT and extubation

  26. Description of the therapeutic changes

    Time frame: Day 1

    A description of the therapeutic changes introduced after the second SBT and before extubation

  27. Relative change in hematocrit

    Time frame: Day 1

    The relative change in hematocrit, between the baseline period and the end of the SBT

  28. Absolute change in NT-pro-BNP

    Time frame: Day 1

    The absolute change in NT-pro-BNP, between the baseline period and the end of the SBT

  29. Absolute change in hematocrit

    Time frame: Day 1

    The absolute change in hematocrit, between the baseline period and the end of the SBT

  30. Relative change in NT-pro-BNP

    Time frame: Day 1

    The relative change in NT-pro-BNP, between the baseline period and the end of the SBT

  31. Relative change in total plasma protein levels

    Time frame: Day 1

    The relative change in total plasma protein levels, between the baseline period and the end of the SBT

  32. Absolute change in total plasma protein levels

    Time frame: Day 1

    The absolute change in total plasma protein levels, between the baseline period and the end of the SBT

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: WAPITI 2

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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