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ClinicalTrials.gov ID

NCT07666880

Lead Sponsor

University Hospital, LimogesOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

88Estimated

Last Update Posted

Jun 24, 2026Actual

Start Date

Aug 1, 2026Estimated

Primary Completion Date

Aug 7, 2029Estimated

Completion Date

Aug 7, 2029Estimated

Official Title

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

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.

• Weaning-induced Pulmonary Edema

• T-piece SBT
• PS-ZEEP SBT

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, LimogesOTHER

philippe.vignon@chu-limoges.fr05 55 05 88 41 ext. +33

jozwiak.m@chu-nice.fr0492035510 ext. +33

denis.doyen@chu-nice.fr0492033622