RecruitingNot ApplicableNCT07059689

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

Sponsor

Indonesia University

Enrollment

114 participants

Start Date

Jun 5, 2025

Study Type

INTERVENTIONAL

Conditions

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

Summary

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

Eligibility

Max Age: 18 Years

Inclusion Criteria4

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 Criteria8

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

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Interventions

DEVICEHigh 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

DEVICENon-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