Randomized Clinical Trial of Spontaneous Breathing Test

Not Applicable

Not yet recruiting

• Conditions: Mechanical Ventilation; Spontaneous Breathing Trial; Extubation Readiness; Extubation Failures; Pediatrics

• Registration Number: NCT06593288
• Lead Sponsor: University of Sao Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-9-9
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients admitted to the PICU on MV for more than 24 hours<br><br> - Patients over 1 month old (corrected gestational age > 38 weeks) and < 18<br> years old on the day of screening for ERT<br><br>Exclusion Criteria:<br><br> - Perinatal-related lung disease<br><br> - Congenital diaphragmatic hernia or congenital/acquired paralysis of the diaphragm<br><br> - Children with heart disease<br><br> - Primary pulmonary hypertension<br><br> - Bronchiolitis obliterans<br><br> - Post-hematopoietic stem cell transplant; specifically, patients receiving continuous<br> supplemental oxygen for three or more days prior to intubation; receiving<br> noninvasive ventilation for more than 24 hours prior to intubation; receiving more<br> than one vasoactive medication at the time of meeting the inclusion criteria;<br> spending more than four days in the PICU prior to intubation; supported by or with<br> immediate plans for renal replacement therapy; with two or more allogeneic<br> transplants; who relapsed after transplant; or with diffuse alveolar hemorrhage<br><br> - Post-lung transplantation<br><br> - Home ventilator dependence with baseline Oxygen Saturation Index (OSI) >6<br> (baseline is defined as a stable period prior to the present illness)<br><br> - Neuromuscular respiratory failure<br><br> - Critical airway obstruction (e.g., post-laryngotracheal surgery or new tracheostomy)<br> or anatomical lower airway obstruction (e.g., mediastinal mass)<br><br> - Facial surgery or trauma in the past two weeks<br><br> - Intracranial bleeding<br><br> - Morbid obesity (2w-24mo: WHO weight-for-length z-score/height z-score =+3; =2y: WHO<br> body mass index (BMI)-for-age z-score =+3)<br><br> - Family/medical team unsupportive total (patient treatment considered futile)<br><br> - Previously enrolled in a current study<br><br> - Enrolled in any other clinical trial with intervention not approved for concomitant<br> enrollment<br><br> - Pregnancy

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extubation failure

Secondary Outcome Measures

Name	Time	Method
Free days of mechanical ventilation