Trial of Spontaneous Breathing Test (NCT06593288) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Trial of Spontaneous Breathing Test
Brazil170 participantsStarted 2025-03-10
Plain-language 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)
Who can participate
Age range1 Month – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…