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
Emory University
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.
Description
This study aims to answer an important clinical question that all providers struggle with: how to optimize respiratory support following extubation in Infants After Cardiac Surgery (CS) for Congenital Heart Disease (CHD). The high morbidity and at times mortality associated with failed extubation events demonstrates this clearly, as extubation failure (EF) is stressful to this fragile population and results in hemodynamic compromise as well as airway trauma due to manipulation of the airway. This study aims to: 1) comparatively examine which mode of respiratory support (HFNC vs NIPPV) after e…
Eligibility
- Age range
- Up to 1 years
- Sex
- All
- Healthy volunteers
- No
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 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.
Interventions
- ProcedureHigh Flow Nasal Canula following extubation
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.
- ProcedureNon-Invasive Positive Pressure Ventilation following extubation
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.
Location
- Arthur M. Blank Hospital | Children's Healthcare of AtlantaAtlanta, Georgia