HFNC vs NIPPV Following Extubation

NCT05869825 | Recruiting DMC

• 2 other identifiers: STUDY000037452025P011091
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Cardiac surgery for CHD; Cardiac Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• To compare the effectiveness in avoiding extubation failures of High Flow Nasal Cannula (HFNC) vs Non-Invasive Positive Pressure Ventilation (NIPPV)

  Rates of extubation failures (EF) will be compared among both groups. Data will be collected from the hospital electronic medical record system.

  After surgery up to 2 weeks

Secondary Outcomes (3)

• Patient's clinical breathing status at discharge

  At hospital discharge up to a year

• Difference of patients' clinical hemodynamical status at discharge

  At hospital discharge up to a year

• Length of hospital stay difference between treatment groups

  From hospital admission until hospital discharge up to a year

Study Arms (2)

The high-flow nasal cannula (HFNC)

ACTIVE COMPARATOR

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).

Procedure: High Flow Nasal Canula following extubation

Non-invasive positive pressure ventilation (NIPPV)

ACTIVE COMPARATOR

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).

Procedure: Non-Invasive Positive Pressure Ventilation following extubation

Interventions

High Flow Nasal Canula following extubation PROCEDURE

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.

Also known as: HFNC

The high-flow nasal cannula (HFNC)

Non-Invasive Positive Pressure Ventilation following extubation PROCEDURE

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.

Also known as: NIPPV

Non-invasive positive pressure ventilation (NIPPV)

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

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

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Asaad Beshish, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asaad Beshish, MD

CONTACT

404.785.6953; beshisha@kidsheart.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 22, 2023
• Study Start: February 27, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)