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

NCT ID: NCT04452188

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2023-04-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normoxia

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.

Group Type: EXPERIMENTAL

Normoxia (with controlled re-oxygenation)

Intervention Type: OTHER

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%)

Standard of care

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

Group Type: ACTIVE_COMPARATOR

Standard of care ventilation

Intervention Type: OTHER

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.

Interventions

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%)

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 29 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Nathaniel Sznycer-Taub

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathaniel Sznycer-Taub, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5UL1TR002240-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00175086

Identifier Type: -

Identifier Source: org_study_id