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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

Qualifiers

Age older than 18 years and < 65 years old

Nasal or oral intubation longer than 24 hours and less than 4 days

Respiratory rate < 35 cycles per minute

SpO2 >90% with FiO2<40% and PEEP<8 cmH2O

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Weaning strategy with direct extubation (no spontaneous breathing trial)
  • Weaning strategy with extubation only after a successful spontaneous breathing

Treatment groups

314 Participants
are divided into 2 treatment groups