Actively Recruiting
HFNC vs NIPPV Following Extubation
Led by Emory University · Updated on 2026-04-29
200
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HFNC vs NIPPV Following Extubation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients admitted to the CICU after cardiac surgery for congenital heart disease
- Age 1 year or younger and/or weight 10 kg or less
You will not qualify if you...
- Intubated continuously for 4 weeks or more
- Have a tracheostomy before cardiac surgery
- Enrolled in another research study
- Require extracorporeal membrane oxygenation (ECMO) support before surgery
- Birth weight less than 2 kg
- Born before 35 weeks gestation
- Have extracardiac anomalies more than minor severity
AI-Screening
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Trial Site Locations
Total: 1 location
1
Arthur M. Blank Hospital | Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Actively Recruiting
Research Team
A
Asaad Beshish, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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