Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period

NACompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

January 18, 2021

Primary Completion Date

April 20, 2023

Study Completion Date

April 20, 2023

Conditions
Hypoplastic Left Heart SyndromeTotal Anomalous Pulmonary Venous ReturnTruncus ArteriosusPulmonary Atresia With Ventricular Septal DefectTransposition of the Great ArteriesDouble Outlet Right Ventricle, Subpulmonary VSDTetralogy of FallotDouble Outlet Right Ventricle With Subaortic Ventricular Septal Defect and Pulmonary StenosisCardiopulmonary Bypass
Interventions
OTHER

Normoxia (with controlled re-oxygenation)

"Participants will receive lower levels of oxygen during surgery and after surgery on the ventilator.~As cardiopulmonary bypass is being weaned, anesthesia will initiate mechanical ventilation with an FiO2 of 50% or less (unless clinically necessary) to achieve oxygen saturation and PaO2 goals that fit within the expected range for the participant's physiology:~1. Single ventricle patients (PaO2:35-45 and oxygen saturation 75%-85%)~2. Two ventricle patients (PaO2: 60-100 and oxygen saturation \>92%)"

OTHER

Standard of care ventilation

As cardiopulmonary bypass is being weaned, anesthesia will initiate mechanical ventilation per standard protocols. Ventilation will be continued in the ICU and adjusted per standard goals per the intensivist.

Trial Locations (1)

48109

University of Michigan, Ann Arbor

All Listed Sponsors
collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

University of Michigan

OTHER

NCT04452188 - Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period | Biotech Hunter | Biotech Hunter