High-flow nasal cannula versus non-invasive ventilation after extubation in children following heart surgery
High Flow Nasal Cannula vs. Non-Invasive Ventilation in Post-Extubation Pediatric Cardiac Surgery Patients: A Randomized Controlled Trial
This compares high-flow nasal cannula and non-invasive ventilation to see which better prevents reintubation in children after heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Indonesia University Academic / other |
| Locations | 1 site (Jakarta, DKI Jakarta) |
| Trial ID | NCT07059689 on ClinicalTrials.gov |
What this trial studies
This interventional study at Cipto Mangunkusumo National General Hospital enrolls children under 18 who are at high risk of extubation failure after cardiac surgery and who pass an extubation readiness test. Participants receive either high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) immediately after extubation, and clinicians track extubation success, CICU length of stay, sedation use, and COMFORT scores. The trial also analyzes clinical factors associated with extubation failure in this high-risk pediatric population.
Who should consider this trial
Good fit: Children under 18 in the CICU after cardiac surgery who are considered high risk for extubation failure (for example young age, open sternotomy, or ventilation >48 hours) and who pass an extubation readiness test are eligible.
Not a fit: Children with diaphragmatic paralysis, decreased consciousness, neuromuscular disease, untreated pneumothorax, airway obstruction, tracheostomy, unplanned extubation, or those requiring PEEP >7 prior to extubation are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If one approach reduces reintubation rates it could shorten CICU stays and lower sedation needs for children recovering from heart surgery.
How similar studies have performed: Similar approaches have been tested with mixed results—noninvasive ventilation has shown benefits in some settings while HFNC is promising but not consistently superior in pediatric post-cardiac cohorts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients under 18 years of age. * Post-cardiac surgery patients in the CICU of Cipto Mangunkusumo National General Hospital * Patients at high risk of extubation failure (e.g., young age, open sternotomy, mechanical ventilation \>48 hours). * Patients who pass the extubation readiness test and spontaneous breathing trial. Exclusion Criteria: * Diaphragmatic paralysis. * Decreased consciousness. * Neuromuscular disease. * Pneumothorax without drainage. * Airway obstruction. * Patients with a tracheostomy. * Unplanned extubation. * Patient received PEEP (Positive End-Expiratory Pressure) \>7 prior to extubation
Where this trial is running
Jakarta, DKI Jakarta
- Faculty of Medicine, University of Indonesia — Jakarta, DKI Jakarta, Indonesia (Recruiting)
Study contacts
- Principal investigator: Head of Pediatric Emergency and Intensive Care Divison — Indonesia University
- Study coordinator: Head of Pediatric Emergency and Intensive Care Divison
- Email: dr.yogiprawira@gmail.com
- Phone: +62811747363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.