Actively Recruiting

Phase Not Applicable
Age: 0 - 1Year
All Genders
NCT05869825

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

Age: 0 - 1Year
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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