Noninvasive respiratory support preventing reintubation after pediatric cardiac surgery-A systematic review.
Ilari Kuitunen, Mikko Uimonen
https://pubmed.ncbi.nlm.nih.gov/38041510Actively Recruiting
Phase Not Applicable
Age: 0 - 18Years
All Genders
ID07059689
High Flow Nasal Cannula vs. Non-Invasive Ventilation in Post-Extubation Pediatric Cardiac Surgery Patients: A Randomized Controlled Trial
Led by Indonesia University · Updated on 2025-07-11
114
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two breathing support methods, High Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV), in children under 18 who have undergone heart surgery and are in the cardiac intensive care unit. The study focuses on how well these methods help prevent the need for reintubation within 48 to 72 hours after planned extubation. It also aims to identify factors that contribute to extubation failure in high-risk pediatric patients. Participants will be randomly assigned to receive either HFNC therapy using the Airvo™3 Nasal High Flow System or NIV with standard ICU ventilator settings tailored to each child's condition immediately after extubation. The study will monitor each group's length of stay in the cardiac intensive care unit, sedation use, and comfort levels measured by the COMFORT scale. Children in the trial will be closely observed for the need for reintubation, duration and amount of sedation, and changes in comfort scores up to 72 hours after extubation. Researchers will also track how long each child stays in intensive care. The total participation time varies but includes monitoring during the critical first few days after surgery. This allows a thorough evaluation of both breathing support methods and their impact on recovery.
CONDITIONS
Brief Title
High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery
Who Can Participate
Age: 0 - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients under 18 years of age
- Post-cardiac surgery patients in the Cardiac Intensive Care Unit of Cipto Mangunkusumo National General Hospital
- Patients at high risk of extubation failure (such as young age, open sternotomy, mechanical ventilation longer than 48 hours)
- Patients who have passed the extubation readiness test and spontaneous breathing trial
You will not qualify if you...
- Diaphragmatic paralysis
- Decreased consciousness
- Neuromuscular disease
- Pneumothorax without drainage
- Airway obstruction
- Patients with a tracheostomy
- Unplanned extubation
- Patient received Positive End-Expiratory Pressure (PEEP) greater than 7 prior to extubation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Implementation
Duration - Up to 72 hours post-extubation
Participants undergo planned extubation after cardiac surgery and receive either High Flow Nasal Cannula (HFNC) therapy or Non-Invasive Ventilation (NIV) immediately following extubation according to their assigned group.
Continuous respiratory support starting immediately after extubation
Post-operative Follow-up
Duration - Up to 1 month post-surgery
Participants are monitored for extubation success, sedation duration and dosage, COMFORT scale scores, and length of stay in the Cardiac Intensive Care Unit.
Regular assessments during CICU stay up to 1 month
Trial Site Locations
Total: 1 location
1
Faculty of Medicine, University of Indonesia
Jakarta, DKI Jakarta, Indonesia, 10430
Actively Recruiting
Loading map...
Research Team
H
Head of Pediatric Emergency and Intensive Care Divison
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Use of high-flow nasal cannula versus other noninvasive ventilation techniques or conventional oxygen therapy for respiratory support following pediatric cardiac surgery: A systematic review and meta-analysis.
Islam Elmitwalli, Eslam Abdelhady, Sidhant Kalsotra...
https://pubmed.ncbi.nlm.nih.gov/38389199Comparison of high-flow nasal cannula oxygenation and non-invasive ventilation for postoperative pediatric cardiac surgery: a meta-analysis.
Si-Jia Zhou, Xiu-Hua Chen, Ying-Ying Liu...
https://pubmed.ncbi.nlm.nih.gov/38383357Safety and Long Term Outcomes with High Flow Nasal Cannula Therapy in Neonatology: A Large Retrospective Cohort Study.
Michael McQueen, Jorge Rojas, Shyan C Sun...
https://pubmed.ncbi.nlm.nih.gov/26167395High-flow nasal cannula oxygen therapy for infants with bronchiolitis: pilot study.
Sara Mayfield, Fiona Bogossian, Lee O'Malley...
https://pubmed.ncbi.nlm.nih.gov/24612137High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial.
Pratik Doshi, Jessica S Whittle, Michael Bublewicz...
https://pubmed.ncbi.nlm.nih.gov/29310868Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries.
Alexandre Demoule, Sylvie Chevret, Annalisa Carlucci...
https://pubmed.ncbi.nlm.nih.gov/26464393High-Flow Nasal Cannula versus Noninvasive Positive Pressure Ventilation in Patients with Heart Failure after Extubation: An Observational Cohort Study.
Che-Jung Chang, Ling-Ling Chiang, Kuan-Yuan Chen...
https://pubmed.ncbi.nlm.nih.gov/32714476Early extubation strategy after congenital heart surgery: 1-year single-centre experience.
Lyudmil Simeonov, Dimitar Pechilkov, Anna Kaneva...
https://pubmed.ncbi.nlm.nih.gov/34092274Influence of Early Extubation Location on Outcomes Following Pediatric Cardiac Surgery.
Sydney R Rooney, Christopher W Mastropietro, Brian Benneyworth...
https://pubmed.ncbi.nlm.nih.gov/32639473