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Not yet recruiting NCT07666880

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

No phase Interventional Weaning-induced Pulmonary Edema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: T-piece SBT, PS-ZEEP SBT.
Who it may be relevant to
Registry conditions: Weaning-induced Pulmonary Edema. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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).
  • 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

Primary outcome measures

  • E/e' ratio [Time frame: Day 1]
Secondary outcome measures (12)
  • Absolute change in the averaged E/e' ratio [Time frame: Day1]
  • Absolute change in arterial pressure [Time frame: day 1]
  • Relative change in arterial pressure [Time frame: Day 1]
  • Number of WIPE cases [Time frame: Day 1]
  • Proportion of WIPE cases [Time frame: Day 1]
  • Number of SBT interruptions [Time frame: Day 1]
  • Absolute change in peak velocity of the mitral E wave [Time frame: Day 1]
  • Relative change in peak velocity of the mitral E wave [Time frame: Day 1]
  • Relative change in peak velocity of the mitral e' wave [Time frame: Day 1]
  • Absolute change in peak velocity of the mitral e' wave [Time frame: Day 1]
  • Absolute change in peak velocity of tricuspid regurgitation [Time frame: Day 1]
  • Relative change in peak velocity of tricuspid regurgitation [Time frame: Day 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Prevention

Study locations

France · 4 centers
  • Ambroise Paré Hospital -APHP — Boulogne-Billancourt
  • Limoges University hospital — Limoges
  • Nice University Hospital - Archet — Nice
  • Nice university hospital - Pasteur — Nice

Identifiers

NCT: NCT07666880 · 87RI25_0075 (WAPITI 2) · 2026-A00509-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗