HFNC vs NIPPV Following Extubation

Description

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

Congenital Heart Disease

Study Overview

Study Details

Study overview

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.

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

HFNC vs NIPPV Following Extubation

Condition
Congenital Heart Disease
Intervention / Treatment

-

Contacts and Locations

Atlanta

Arthur M. Blank Hospital | Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

to 1 Year

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

Asaad Beshish, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2026-05