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

University of Indonesia (UI)

Status: Enrolling

Conditions: Heart Defects, Congenital; Respiration, Artificial; Intensive Care Units, Pediatric; Extubation

Treatments: Device: Non-Invasive Ventilation (NIV); Device: High Flow Nasal Cannula (HFNC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07059689

24-04-0565

Details and patient eligibility

About

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

Full 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.

Enrollment: 114 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

High Flow Nasal Cannula

Experimental group

Description:

Participants in this arm will receive High Flow Nasal Cannula (HFNC) therapy using the Airvo™3 Nasal High Flow System immediately following planned extubation after cardiac surgery.

Treatment:

Device: High Flow Nasal Cannula (HFNC)

Non-Invasive Ventilation (NIV)

Active Comparator group

Description:

Participants in this arm will receive Non-Invasive Ventilation (NIV) immediately following planned extubation after cardiac surgery, in accordance with institutional protocols.

Treatment:

Device: Non-Invasive Ventilation (NIV)