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Recruiting NCT05869825

HFNC vs NIPPV Following Extubation

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Trial Parameters

Condition Congenital Heart Disease
Sponsor Emory University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age N/A
Max Age 1 Year
Start Date 2025-02-27
Completion 2026-05
Interventions
High Flow Nasal Canula following extubationNon-Invasive Positive Pressure Ventilation following extubation

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Brief Summary

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.

Eligibility Criteria

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 in place 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.

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