High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery
Launched by INDONESIA UNIVERSITY · Jul 7, 2025
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different ways to help children breathe after they have had heart surgery and had a breathing tube removed. The trial compares using a high-flow nasal cannula, which delivers extra oxygen through soft tubes in the nose, with non-invasive ventilation (NIV), a method that helps support breathing with a mask or similar device without putting a tube down the throat. The goal is to see which method works better to support children’s breathing during this critical time.
Children under 18 who have just had heart surgery at a specific hospital and are at higher risk of breathing problems after the tube is removed may be eligible to join. These children must have passed tests that show they are ready to breathe on their own. Kids with certain conditions like nerve or muscle problems affecting breathing, lung collapse without treatment, or those who had unexpected removal of the breathing tube are not eligible. If a child joins the trial, their doctors will carefully monitor them after extubation using one of the two breathing support methods to see which helps them recover better. This study is currently looking for participants.
Gender
ALL
Eligibility 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
About Indonesia University
Indonesia University is a leading academic institution dedicated to advancing healthcare through rigorous clinical research. As a trial sponsor, the university leverages its extensive expertise in medical science and collaboration with top-tier researchers to design and implement innovative clinical trials. Committed to ethical standards and patient safety, Indonesia University aims to contribute to the global body of knowledge in medicine, enhance therapeutic options, and improve health outcomes for diverse populations. Through its comprehensive approach, the university fosters an environment of scientific inquiry and collaboration, driving progress in clinical research and education.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jakarta, Dki Jakarta, Indonesia
Patients applied
Trial Officials
Head of Pediatric Emergency and Intensive Care Divison
Principal Investigator
Indonesia University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported