Weaning-induced Pulmonary EdemaWAPITI 2NCT07666880
Hemodynamic Impact of the Spontaneous Ventilation Test in Patients at Risk of Weaning Pulmonary Oedema
A study testing T-piece SBT and PS-ZEEP SBT in people with Weaning-induced Pulmonary Edema, run by University Hospital, Limoges at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning-induced Pulmonary Edema
- What is being tested?
- T-piece SBT and PS-ZEEP SBT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Aug 2026to 7 Aug 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Ambroise Paré Hospital -APHP
Boulogne-Billancourt, 92100
Adrien JOSEPH, MD, 0149095601, adrien.joseph@aphp.fr
Adrien JOSEPH, MD
Limoges University hospital
Limoges, 87042
Philippe VIGNON, MD, 05 55 05 88 41 ext. +33, philippe.vignon@chu-limoges.fr
Philippe VIGNON, MD
Nice University Hospital - Archet
Nice, 06000
Mathieu JOZWIAK, MD, 0492035510 ext. +33, jozwiak.m@chu-nice.fr
Mathieu JOZWIAK, MD
Nice university hospital - Pasteur
Nice, 06000
denis DOYEN, MD+33, 0492033622, denis.doyen@chu-nice.fr
Denis DOYEN, MD
About this study
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.
- Conditions
- Weaning-induced Pulmonary Edema
- Being tested
- T-piece SBT, PS-ZEEP SBT
- Keywords
- Weaning-induced pulmonary edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-piece SBTProcedure or surgery
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 SBTProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| T-piece SBT then PS-ZEEP SBT | Experimental | In this arm, T-piece SBT will be evaluated first and PS-ZEEP SBT in a second time. Receives: Procedure: T-piece SBT |
| PS-ZEEP SBT then T-piece SBT | Experimental | In this arm, PS-ZEEP SBT will be evaluated first and T-piece SBT ina second time. Receives: Procedure: PS-ZEEP SBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
E/e' ratio
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)
Measured: Day 1
Secondary outcomes (32)
Absolute change in the averaged E/e' ratio
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
Measured: Day1
Absolute change in arterial pressure
The absolute change in arterial pressure between the baseline period and the end of the SBT
Measured: day 1
Relative change in arterial pressure
The relative change in arterial pressure between the baseline period and the end of the SBT
Measured: Day 1
Number of WIPE cases
The number of WIPE cases
Measured: Day 1
Proportion of WIPE cases
The proportion of WIPE cases
Measured: Day 1
Number of SBT interruptions
The number of SBT interruptions related to WIPE
Measured: Day 1
Absolute change in peak velocity of the mitral E wave
The absolute change in the peak velocity of the mitral E wave at the lateral and septal mitral annulus
Measured: Day 1
Relative change in peak velocity of the mitral E wave
The relative change in the peak velocity of the mitral E wave at the lateral and septal mitral annulus
Measured: Day 1
Relative change in peak velocity of the mitral e' wave
The relative change in the peak velocity of the mitral e' wave at the lateral and septal mitral annulus
Measured: Day 1
Absolute change in peak velocity of the mitral e' wave
The absolute change in the peak velocity of the mitral e' wave at the lateral and septal mitral annulus
Measured: Day 1
Absolute change in peak velocity of tricuspid regurgitation
The absolute change in the peak velocity of tricuspid regurgitation
Measured: Day 1
Relative change in peak velocity of tricuspid regurgitation
The relative change in the peak velocity of tricuspid regurgitation
Measured: Day 1
Number of clinically relevant mitral regurgitation
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
Measured: Day 1
Proportion of clinically relevant mitral regurgitation
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
Measured: Day 1
Semi-quantitative assessment of clinically relevant mitral regurgitation
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
Measured: Day 1
Number of dynamic left ventricular outflow tract obstruction
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
Measured: Day 1
Proportion of dynamic left ventricular outflow tract obstruction
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
Measured: Day 1
Semi-quantitative assessment of dynamic left ventricular outflow tract obstruction
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
Measured: Day 1
Lung ultrasound aeration score
The lung ultrasound aeration score (0 to 3) across all 12 quadrants between the baseline period and the end of the SBT
Measured: Day 1
The number of SBTs performed
The number of SBTs performed before extubation
Measured: Day 1
The type of SBTs performed
The type of SBTs performed before extubation
Measured: Day 1
Duration of such ventilatory support
The Duration of such ventilatory support
Measured: Day 1
Number of patients requiring ventilatory support
The number of patients requiring ventilatory support with high-flow oxygen therapy (e.g., Optiflow©) or non-invasive ventilation
Measured: Day 1
Number of patients requiring reintubation for mechanical ventilation
The number of patients requiring reintubation for mechanical ventilation within the week following extubation (extubation failure); the day of reintubation, where applicable
Measured: Day 7
The number of hours between the second SBT and extubation
The number of hours between the second SBT and extubation
Measured: Day 1
Description of the therapeutic changes
A description of the therapeutic changes introduced after the second SBT and before extubation
Measured: Day 1
Relative change in hematocrit
The relative change in hematocrit, between the baseline period and the end of the SBT
Measured: Day 1
Absolute change in NT-pro-BNP
The absolute change in NT-pro-BNP, between the baseline period and the end of the SBT
Measured: Day 1
Absolute change in hematocrit
The absolute change in hematocrit, between the baseline period and the end of the SBT
Measured: Day 1
Relative change in NT-pro-BNP
The relative change in NT-pro-BNP, between the baseline period and the end of the SBT
Measured: Day 1
Relative change in total plasma protein levels
The relative change in total plasma protein levels, between the baseline period and the end of the SBT
Measured: Day 1
Absolute change in total plasma protein levels
The absolute change in total plasma protein levels, between the baseline period and the end of the SBT
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion7 Aug 2029 (estimated)
- Study completion7 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning-induced Pulmonary EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666880
- Sponsor's protocol ID
- 87RI25_0075 (WAPITI 2)
- Other IDs
- 2026-A00509-42
- Acronym
- WAPITI 2
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No