NOT_YET_RECRUITING
HFNC vs NIPPV Following Extubation
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 Start (Actual) October 2024
🗓️ Primary Completion (Estimated) May 2025
✅ Study Completion (Estimated) May 2026
👥 Enrollment (Estimated) 200
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    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 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: N/A to 1 Year (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 March 2023
  • First Submitted that Met QC Criteria 19 May 2023
  • First Posted 22 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 July 2024
  • Last Update Posted 17 July 2024
  • Last Verified July 2024