Recruiting

HFNC vs. NIPPV

Sponsor:

Emory University

Code:

NCT05869825

Conditions

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

High Flow Nasal Canula following extubation

Non-Invasive Positive Pressure Ventilation following extubation

Study Details

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.

Conditions

Congenital Heart Disease

Study ID

NCT05869825

Start date

Feb 27, 2025

Status verified date

Jul, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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 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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: The high-flow nasal cannula (HFNC)

The high flow nasal cannula (HFNC) is a unique mode of respiratory support that delivers warmed, humidified oxygen with a wide range of fractions of inspired oxygen (FiO2) and flow rate (liters/min) without an invasive device such as an endotracheal tube (breathing tube).

active comparator: Non-invasive positive pressure ventilation (NIPPV)

Non-invasive positive pressure ventilation (NPPV or NIPPV) is a unique mode of respiratory support that delivers pressurized, oxygen-enriched gas to the airway via the nose and/or oropharynx without a more invasive device such as an endotracheal tube (breathing tube).

Interventions

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 require re-intubation.

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 require re-intubation.

Primary outcome measure

  • To compare the effectiveness in avoiding extubation failures of High Flow Nasal Cannula (HFNC) vs Non-Invasive Positive Pressure Ventilation (NIPPV) [ Time Frame: After surgery up to 2 weeks ]

Central Contacts and Locations

Central contacts

Asaad Beshish, MD

404.785.6953beshisha@kidsheart.com

Locations

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

Recruiting

Atlanta, Georgia, United States, 30329

More Information

Sponsor

Emory University

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Cardiac surgery for CHD
  • Cardiac Intensive Care Unit

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-07-14.