Direct Extubation Versus Extubation After a Spontaneous Breathing Trial in Patients at Low Risk of Extubation Failure

Recruiting now · Not applicable

Conditions studied: Weaning From Mechanical Ventilation, Extubation

In brief

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).

Key facts

Study ID

NCT07019636

Run by

Assistance Publique - Hôpitaux de Paris

People needed

314

Starts

2026-07-15

Expected to finish

2028-10-15

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age older than 18 years and < 65 years old
• Nasal or oral intubation longer than 24 hours and less than 4 days
• Satisfaction to each following weaning readiness criteria:
• Respiratory rate < 35 cycles per minute
• SpO2 >90% with FiO2<40% and PEEP<8 cmH2O
• RASS score between -2 and +2 with low level or no sedatives
• No need or low doses of vasopressors
• Adequate cough
• Inform consent by patient or legal representative or the close relative or emergency inclusion procedure.

You may not qualify if…

• Risk factor for extubation failure as defined by any of the following criteria:
• Chronic cardiac disease (left ejection fraction below 45%, documented history of cardiogenic pulmonary edema, permanent atrial fibrillation).
• Chronic respiratory disease (severe COPD, documented restricted lung disease or obesity-hypoventilation syndrome)
• Body mass index > 30 kg/m2
• Airway patency problems, including high risk of developing laryngeal edema, inability to deal with respiratory secretions, brain injury, documented swallowing disorders
• Tracheostomy
• Underlying chronic neuromuscular disease
• Do not resuscitate orders
• Pregnant or lacting woman
• Patient under guardianship
• Patient without healthcare insurance
• Refusal to participate and sign the written consent
• Patients with traumatic brain injury
• Post surgery patients
• Patients included in another interventional trial that may have an impact on the evaluation criteria of the present study
• Patient under AME

Where it is running

• Hôpital Pitié Salpêtrière — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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