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RecruitingNot ApplicableNCT07019636

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

314 participants

Start Date

Jul 15, 2026

Study Type

INTERVENTIONAL

Conditions

Weaning From Mechanical Ventilation, Extubation

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).

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria9

  • 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.

Exclusion Criteria16

  • 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

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Interventions

PROCEDUREWeaning strategy with direct extubation (no spontaneous breathing trial)

Patients will be extubated within the 60 minutes following randomization

PROCEDUREWeaning 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

Locations(1)

Hôpital Pitié Salpêtrière

Paris, France

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NCT07019636