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Clinical Trials in Brazil / NCT06593288
Starting soon Not applicable

Trial of Spontaneous Breathing Test

NCT06593288 · tracked via the Priya Life Science Brazil tracker
Phase
Not applicable
Started
2025-03-10
Last updated
2024-12-06

Condition(s) studied

Mechanical VentilationSpontaneous Breathing TrialExtubation ReadinessExtubation FailuresPediatrics

Investigational drug(s) / intervention(s)

Pressure Support Ventilationcontinuous positive airway pressure (CPAP)

Pressure Support Ventilation: Conduct the Spontaneous breathing trial with pressure support

continuous positive airway pressure (CPAP): Conduct the spontaneous breathing trial with CPAP

Study summary

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

Sex
ALL
Min age
1 Month
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Perinatal-related lung disease * Congenital diaphragmatic hernia or congenital/acquired paralysis of the diaphragm * Children with heart disease * Primary pulmonary hypertension * Bronchiolitis obliterans * Post-hematopoietic stem cell transplant; specifically, patients receiving continuous supplemental oxygen for three or more days prior to intubation; receiving noninvasive ventilation for more than 24 hours prior to intubation; receiving more than one vasoactive medication at the time of meeting the inclusion criteria; spending more than four days in the PICU prior to intubation; supported by or with immediate plans for renal replacement therapy; with two or more allogeneic transplants; who relapsed after transplant; or with diffuse alveolar hemorrhage * Post-lung transplantation * Home ventilator dependence with baseline Oxygen Saturation Index (OSI) \>6 (baseline is defined as a stable period prior to the present illness) * Neuromuscular respiratory failure * Critical airway obstruction (e.g., post-laryngotracheal surgery or new tracheostomy) or anatomical lower airway obstruction (e.g., mediastinal mass) * Facial surgery or trauma in the past two weeks * Intracranial bleeding * Morbid obesity (2w-24mo: WHO weight-for-length z-score/height z-score ≥+3; ≥2y: WHO body mass index (BMI)-for-age z-score ≥+3) * Family/medical team unsupportive total (patient treatment considered futile) * Previously enrolled in a current study * Enrolled in any other clinical trial with intervention not approved for concomitant enrollment * Pregnancy

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo Ribeirão Preto São Paulo

More University of Sao Paulo trials in Brazil

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06593288 on ClinicalTrials.gov ↗ ← All trials in Brazil