Direct Extubation Versus Extubation After a Spontaneous Breathing Trial in Patients at Low Risk of Extubation Failure
NCT07019636 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 314
Last updated 2025-06-19
Summary
This randomized controlled open label trial aims at comparing a weaning strategy including a spontaneous breathing trial as a prerequisite for extubation to a weaning strategy without a spontaneous breathing trial (direct extubation) in patients with readiness to be weaned criteria and considered at low risk of extubation failure. The main endpoint will be the proportion of patients successfully extubated within the 24 hours after randomization as compared to extubation after a successful spontaneous breathing trial (SBT).
Conditions
- Weaning From Mechanical Ventilation, Extubation
Interventions
- PROCEDURE
-
Weaning strategy with direct extubation (no spontaneous breathing trial)
Patients will be extubated within the 60 minutes following randomization
- PROCEDURE
-
Weaning strategy with extubation only after a successful spontaneous breathing
Patients will undergo a spontaneous breathing trial and will be extubated only in case of successful spontaneous breathing
Sponsors & Collaborators
-
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Martin DRES, Pr · Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-15
- Primary Completion
- 2027-09-18
- Completion
- 2027-10-15
Countries
- France
Study Locations
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