Trial of Spontaneous Breathing Test

Launched by UNIVERSITY OF SAO PAULO · Sep 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called the Spontaneous Breathing Test (SBT) to see if it can help children who are on mechanical ventilation (a machine that helps them breathe) to breathe on their own again. The researchers want to find out if doing the test without extra breathing support is just as effective as doing it with support. They will compare two groups of children: one group will have the test with some pressure support, while the other group will only have a specific setting called PEEP to help keep their airways open. The main goals are to see if the test can help children successfully breathe without the ventilator and to understand how long they might need to stay in the intensive care unit (PICU).

To be eligible for this trial, children must be between 1 month and 17 years old and have been on mechanical ventilation for more than 24 hours. However, some children may not be able to participate if they have certain medical conditions, such as severe lung diseases or recent surgeries. The trial is not yet recruiting participants, but once it starts, children who join can expect to undergo the breathing tests and be monitored closely for their recovery. It’s important for families to discuss any concerns with their medical team before considering participation in the study.

Gender

ALL

Eligibility criteria

• 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