NCT04452188

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 29 Days
• Healthy volunteers: Not accepted

Summary

This clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery. In addition to having the various doses of oxygen, participants will also have blood samples, ultrasounds of the head, and brain wave patterns monitored. The hypotheses of this trial are: * that there will be no difference with regards to adverse events between the infants in the normoxia group compared to the infants in the standard of care group * there will be a significant difference in the measured partial pressure of oxygen (PaO2) values between the two treatment groups. * the use of normoxia during cardiopulmonary bypass and in the immediate post-operative period will result in clinically significant decrease in oxidative stress as measured by thiobarbituric acid reactive substances (TBARS) after cardiac surgery

Conditions

• Hypoplastic Left Heart Syndrome
• Total Anomalous Pulmonary Venous Return
• Truncus Arteriosus
• Pulmonary Atresia With Ventricular Septal Defect
• Transposition of the Great Arteries
• Double Outlet Right Ventricle, Subpulmonary VSD
• Tetralogy of Fallot
• Double Outlet Right Ventricle With Subaortic Ventricular Septal Defect and Pulmonary Stenosis
• Cardiopulmonary Bypass

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-18
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2020-06-30
• Last updated: 2024-06-18
• Results posted: 2024-06-18

Locations

1 site across 1 country: United States