The main objective will be to compare the number of ventilator-free days within the 28 days following the first spontaneous breathing trial between strategies of extubation performing spontaneous breathing trials with T-piece trials or with Pressure-Support trials. To do that, the study director proposed to conduct a prospective multicenter randomized controlled open-label trial comparing these 2 strategies of weaning in patients at high-risk of extubation failure in the Intensive Care Unit. Patients included will be randomized before performing the first spontaneous breathing trial and will be assigned to one of the following two groups according to the weaning strategy: T-piece trial group or Pressure-Support trial group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
1,000
T-piece trial will be performed for around 1 hour with a T-piece connected to the extremity of the endotracheal tube by simply disconnecting the patient from the ventilator and by providing additional oxygen (≤ 6 L/min)
Pressure-Support trial will be performed for around 1 hour without disconnecting the patient from the ventilator, by using a low level of pressure-support (PS 8 cm H2O) with a FiO2 ≤ 40% and without positive end-expiratory pressure (PEEP), while continuously monitoring the respiratory rate and tidal volume on the ventilator display.
Intensive reanimation
Poitiers, France
Number of ventilator-free days at day 28
The number of ventilator-free days at day 28, defined as the number of days alive and without invasive mechanical ventilation (intubation or tracheostomy) between the first spontaneous breathing trial (day 1) and day 28.
Time frame: Day 28
The number of days alive and without mechanical ventilation (including intubation or non-invasive ventilation) between the first spontaneous breathing trial (day 1) and day 28.
Time frame: Between Day 1 and Day 28
The number of patients extubated within the 72 hours and within the 7 days following the first spontaneous breathing trial.
Time frame: Hour 72, Day 7
The number of patients extubated after simple (24h), difficult (> 24 hours and ≤ 7 days) or prolonged ( > 7 days) weaning
Time frame: Day 28
The number of patients extubated after the first spontaneous breathing trial and not reintubated within the following 72 hours.
Time frame: Hour 72
The number of days between the first spontaneous breathing trial and the first extubation attempt among extubated patients
Time frame: Day 28
The number of patients reintubated within the 72 hours and within the 7 days following extubation.
Time frame: Day 28
The number of patients with post-extubation respiratory failure within the 7 days following extubation.
Time frame: Day 28
Length of stay in ICU in days.
Time frame: Day 90
Numbers of patients died in ICU, at day 28 and at day 90.
Time frame: Day 28 and Day 90
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