Trial of Spontaneous Breathing Test

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorUniversity of Sao Paulo

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Pressure Support Ventilation

    Other intervention

    Conduct the Spontaneous breathing trial with pressure support

  • continuous positive airway pressure (CPAP)

    Other intervention

    Conduct the spontaneous breathing trial with CPAP

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Spontaneous breathing trial with pressure supportActive comparator 1 intervention
Group B: Spontaneous breathing trial without pressure supportActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Extubation failure

Extubation failure: patient needs to be reintubated less than 48 hours after extubation

Time frame
48 hours

Secondary outcomes

1

Free days of mechanical ventilation

Free days of mechanical ventilation

Time frame
30 days

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: