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HFNC vs NIPPV Following Extubation

High Flow Nasal Cannula and Non-Invasive Positive Pressure Ventilation Following Extubation in Infants After Cardiac Surgery for Congenital Heart Disease: A Randomized Clinical Trial

Who can join

Up to age 1 · All sexes

Inclusion Criteria:

* All patients admitted to the CICU following cardiac surgery for CHD who are \</= 1 year of age and/or weight \</= 10 kg

Exclusion Criteria:

* Patients who remain intubated for \>/= 4 weeks
* Patients who have a tracheostomy prior to their cardiac surgery
* Patient enrolled in a competing research study
* Patients requiring extracorporeal membrane oxygenation (ECMO) support preoperatively
* Patients with birth weight \< 2 Kg.
* Gestational age \< 35 weeks at birth.
* Patients with extracardiac anomalies more than minor severity.

About the study

This study has the goal to determine the best method of respiratory support following extubation after cardiac surgery (CS). After cardiac surgery for Congenital Heart Disease (CHD), patients remain intubated until the cardiac team determines it is safe for the patient to undergo a trial of extubation. Two common methods of respiratory support following extubation are High Flow Nasal Cannula (HFNC) and Non Invasive Positive Pressure Ventilation (NIPPV). There is currently a gap in data comparing High Flow Nasal Cannula and Non-Invasive Positive Pressure Ventilation in infants (age 0-1) in regard to extubation failure and overall outcomes.

This study will monitor the health outcomes of 200 infants (0 - 1 year) with CHD following cardiac surgery in the Cardiac Intensive Care Unit (CICU) at Children's Healthcare of Atlanta (CHOA). This will be done by assigning the respiratory support method each child will receive following extubation after cardiac surgery. Health outcomes will be monitored until discharge or until the second instance of extubation failure.

Both study arms are standard-of-care respiratory support methods in the CHOA CICU. The investigators aim to determine which of these two methods has fewer risk factors when used with infants.

What is being tested

• High Flow Nasal Canula following extubation (procedure)
• Non-Invasive Positive Pressure Ventilation following extubation (procedure)

Sponsor: Emory University · Participants: 200 · Started: Feb 27, 2025

Contact the study team

• Asaad Beshish, MD · Phone: 404.785.6953

Official record on ClinicalTrials.gov — NCT05869825

Locations in the U.S.

Conditions

• Congenital Heart Defects

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.