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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Weaning strategy with direct extubation (no spontaneous breathing trial)
Procedure/SurgeryPatients will be extubated within the 60 minutes following randomization
Weaning strategy with extubation only after a successful spontaneous breathing
Procedure/SurgeryPatients will undergo a spontaneous breathing trial and will be extubated only in case of successful spontaneous breathing
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients extubated within the 24 hours after randomization and who will remain free from mechanical ventilation until 72 hours.
The rate of patients extubated within the 24 hours after randomization and who will remain free from mechanical ventilation until 72 hours.
Secondary outcomes
Occurrence of post extubation acute respiratory failure
Rate of post extubation acute respiratory failure defined by the persistence of more than 30 minutes of at least two predefined criteria
Occurrence of reintubation
Rate of of reintubation with predefined criteria
Unplanned use of non-invasive ventilation or high flow nasal oxygen
Rate of unplanned use of non-invasive ventilation or high flow nasal oxygen
Duration of weaning process from randomization until successful extubation
Number of days from randomization until successful extubation
Sponsors and contacts
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