HFNC vs NIPPV Following Extubation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorEmory University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • High Flow Nasal Canula following extubation
  • Non-Invasive Positive Pressure Ventilation following extubation

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators