About this trial
The hypothesis is that the Spontaneous Breathing Test (SBT) without pressure support (PS) is not inferior to the SBT with pressure support in relation to the following outcomes: a) extubation failure; b) time on MV.
The main objective of this study is to determine whether SBT without PS is non-inferior to SBT with PS in relation to the primary outcome: a) extubation failure; and secondary outcomes: b) length of stay in the PICU and c) days free of MV.
Pacients will be randomized to 2 arms:
1. SBT with PS 2. SBT without PS (with PEEP only)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients admitted to the PICU on MV for more than 24 hours
Patients over 1 month old (corrected gestational age > 38 weeks) and < 18 years old on the day of screening for ERT
Disqualifiers
Perinatal-related lung disease
Congenital diaphragmatic hernia or congenital/acquired paralysis of the diaphragm
Children with heart disease
Primary pulmonary hypertension
Trial design
Parallel
Treatments tested in this trial
Pressure Support Ventilation
Other interventionConduct the Spontaneous breathing trial with pressure support
continuous positive airway pressure (CPAP)
Other interventionConduct the spontaneous breathing trial with CPAP
Treatment groups
Trial outcomes
Primary outcomes
Extubation failure
Extubation failure: patient needs to be reintubated less than 48 hours after extubation
Secondary outcomes
Free days of mechanical ventilation
Free days of mechanical ventilation
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: