Status:
NOT_YET_RECRUITING
Trial of Spontaneous Breathing Test
Lead Sponsor:
University of Sao Paulo
Conditions:
Mechanical Ventilation
Spontaneous Breathing Trial
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief 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;...
Detailed Description
Introduction Mechanical ventilation (MV) is a common procedure for patients admitted to pediatric intensive care units (PICUs). Although MV is often necessary and life-saving, it can be associated wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06593288
Start Date
March 10 2025
End Date
April 1 2026
Last Update
December 6 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto, São Paulo, Brazil, 14015-010