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

University of Michigan

Status: Completed

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

Treatments: Other: Standard of care ventilation; Other: Normoxia (with controlled re-oxygenation)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04452188

HUM00175086

5UL1TR002240-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: All

Ages: Under 29 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age less than 30 days of age at time of surgery with need for cardiopulmonary bypass with cardioplegic arrest (with or without deep hypothermic circulatory arrest)

• Diagnosis with cyanosis at baseline (pre-operative PaO2 of less than 50mmHG) due to:

  • Complete admixture lesion (example: hypoplastic left heart syndrome, total anomalous pulmonary venous return, truncus arteriosus, pulmonary atresia with VSD)
  • Transposition physiology (example: D-Transposition of the great arteries or Double outlet right ventricle with subpulmonary VSD)
  • Right-to-left shunt (example: Tetralogy of Fallot, double outlet right ventricle with subaortic VSD and pulmonary stenosis)

Exclusion criteria

• Corrected gestation at time of surgery less than 37 weeks
• Prior cardiac arrest
• Current or prior history of extracorporeal membrane oxygenation (ECMO) support
• Current or prior history of needing renal replacement therapy with dialysis
• Prior cardiac surgery requiring cardiopulmonary bypass
• Diagnosis of Ebstein's Anomaly
• Known genetic syndrome other than Trisomy 21 or DiGeorge Syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Normoxia

Experimental group

Description:

On bypass, goal PaO2 on cardiopulmonary bypass of 60-100 mm Hg using lower fraction of inspired oxygen (FiO2) (blended sweep gas) via oxygenator Post-bypass, goal of PaO2 \<100 mm Hg by anesthesia and in ICU via oxygen titration via mechanical ventilator for 24 hours post-op.

Treatment:

Other: Normoxia (with controlled re-oxygenation)

Standard of care

Active Comparator group

Description:

Frequent blood gases will be checked per protocol on bypass and correlated with the blood parameter monitoring system to maintain a PaO2 of 200-300 per standard practice

Treatment:

Other: Standard of care ventilation