RECRUITING

HFNC vs NIPPV Following Extubation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-27
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05869825

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.

Ages Eligible for Study:Not specified to 1 Year
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * All patients admitted to the CICU following cardiac surgery for CHD who are \</= 1 year of age and/or weight \</= 10 kg
  1. * Patients who remain intubated for \>/= 4 weeks
  2. * Patients who have a tracheostomy in place prior to their cardiac surgery
  3. * Patient enrolled in a competing research study
  4. * Patients requiring extracorporeal membrane oxygenation (ECMO) support preoperatively
  5. * Patients with birth weight \< 2 Kg.
  6. * Gestational age \< 35 weeks at birth.
  7. * Patients with extracardiac anomalies more than minor severity.

Contacts and Locations

Study Contact

Asaad Beshish, MD
CONTACT
404.785.6953
beshisha@kidsheart.com

Principal Investigator

Asaad Beshish, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Emory University

  • Asaad Beshish, MD, PRINCIPAL_INVESTIGATOR, Emory University

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

Study Start Date2025-02-27
Study Completion Date2026-05

Study Record Updates

Study Start Date2025-02-27
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • Cardiac surgery for CHD
  • Cardiac Intensive Care Unit

Additional Relevant MeSH Terms

  • Congenital Heart Disease