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

NCT07666880 | Not Yet Recruiting

• 2 other identifiers: 87RI25_0075 (WAPITI 2)2026-A00509-42
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 4

Brief 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. 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

Keywords

Weaning-induced pulmonary edema

Outcome Measures

Primary Outcomes (1)

• 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)

  Day 1

Secondary Outcomes (32)

• Absolute change in the averaged E/e' ratio

  Day1

• Absolute change in arterial pressure

  day 1

• Relative change in arterial pressure

  Day 1

• Number of WIPE cases

  Day 1

• Proportion of WIPE cases

  Day 1

Study Arms (2)

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.

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.

Procedure: PS-ZEEP SBT

Interventions

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).

T-piece SBT then PS-ZEEP SBT

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).

PS-ZEEP SBT then T-piece SBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (4)

Ambroise Paré Hospital -APHP

Boulogne-Billancourt, 92100, France

Location

Limoges University hospital

Limoges, 87042, France

Location

Nice University Hospital - Archet

Nice, 06000, France

Location

Nice university hospital - Pasteur

Nice, 06000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 7, 2029
• Study Completion (Estimated): August 7, 2029
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)