NCT07059689

High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery

High Flow Nasal Cannula vs. Non-Invasive Ventilation in Post-Extubation Pediatric Cardiac Surgery Patients: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery

Detailed description

This study aims to compare the extubation success rate between the use of High Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV) in pediatric patients post-cardiac surgery at the Cipto Mangunkusumo National General Hospital. Additionally, this study seeks to identify factors influencing extubation failure in high-risk patient populations, compare CICU length of stay, sedation usage and COMFORT scale between patients receiving HFNC and those receiving NIV.

Conditions

• Heart Defects, Congenital
• Intensive Care Units, Pediatric
• Respiration, Artificial
• Extubation

Interventions

Type	Name	Description
DEVICE	High Flow Nasal Cannula (HFNC)	Participants in this arm will receive High Flow Nasal Cannula therapy using the Airvo™3 Nasal High Flow System immediately after planned extubation following cardiac surgery
DEVICE	Non-Invasive Ventilation (NIV)	Participants in this arm will receive Non-Invasive Ventilation (NIV) immediately after planned extubation following cardiac surgery. NIV will be delivered using standard ICU ventilator settings, with parameters tailored to each patient's clinical condition

Timeline

• Start date: 2025-06-05
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-07-11
• Last updated: 2025-07-11

Locations

1 site across 1 country: Indonesia