High-flow nasal cannula versus non-invasive ventilation after extubation in children following heart surgery
Official title: High Flow Nasal Cannula vs. Non-Invasive Ventilation in Post-Extubation Pediatric Cardiac Surgery Patients: A Randomized Controlled Trial
Run by Universitas Indonesia · NCT07059689 · Data updated 2026-11-12
This compares high-flow nasal cannula and non-invasive ventilation to see which better prevents reintubation in children after heart surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 114 (estimated) |
| Sponsor | Universitas Indonesia Academic / other |
| Locations | 1 site (Jakarta, DKI Jakarta) |
| Status | Recruiting |
| Started | June 5, 2025 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | July 11, 2025 |
| Trial ID | NCT07059689 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Faculty of Medicine, University of Indonesia
Jakarta, DKI Jakarta, Indonesia Recruiting
Study contacts
- Principal investigator: Head of Pediatric Emergency and Intensive Care Divison — Universitas Indonesia
- Study coordinator: Head of Pediatric Emergency and Intensive Care Divison
- Email: dr.yogiprawira@gmail.com
- Phone: +62811747363
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Can a chest heart rhythm monitor help predict when ICU patients on a ventilator can breathe without the tube?
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This study tests whether extubations done during on-hours have fewer acute airway/respiratory problems in the first 30 minutes after extubation compared with extubations done off-hours in adults undergoing general anesthesia.
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Ventilation During Transport of Mechanically Ventilated Patients After Non-Cardiac Surgery
This observational study looks at how patients who stay intubated after non-cardiac surgery are ventilated during the move from the operating room to the ICU.
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Endotracheal suctioning during positive-pressure extubation in the ICU
This tests whether doing endotracheal suctioning during positive-pressure extubation helps adults on mechanical ventilation have better oxygenation (ROX) three hours after extubation.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.