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RECRUITING
NCT05869825
NA

HFNC vs NIPPV Following Extubation

Sponsor: Emory University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - 1 Year

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-02-27

Completion Date

2026-05

Last Updated

2025-04-08

Healthy Volunteers

No

Interventions

PROCEDURE

High Flow Nasal Canula following extubation

Participants in this group will be randomized to receive High Flow Nasal Cannula support after extubation. The patient will be clinically monitored and respiratory support will be escalated per a specific flow sheet. The patient will remain on this assigned air support method until they are either removed entirely from air support or need to be re-intubated with oxygen.

PROCEDURE

Non-Invasive Positive Pressure Ventilation following extubation

Participants in this group will be randomized to receive NIPPV respiratory support following extubation. The patient will be clinically monitored and respiratory support will be escalated per a specific flow sheet. The patient will remain on this assigned air support method until they are either removed entirely from air support or need to be re-intubated with oxygen.

Locations (1)

Arthur M. Blank Hospital | Children's Healthcare of Atlanta

Atlanta, Georgia, United States