HFNC vs NIPPV Following Extubation

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05869825
Status
Recruiting
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Conditions

  • Congenital Heart Disease

Eligibility Criteria

Sex
ALL
Age
N/A - 1 Year
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 27, 2025
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

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

Locations (1)

FacilityCityStateZIPSite coordinators
Arthur M. Blank Hospital | Children's Healthcare of AtlantaAtlantaGeorgia30329-

Find similar trials in Atlanta, GA

By research site
Arthur M. Blank Hospital | Children's Healthcare of Atlanta· Atlanta, GA

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