Nitric Oxide During Bypass for Arterial Switch Operation

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This trial will test if adding nitric oxide (NO) gas to the cardiopulmonary bypass (CPB) circuit in infants undergoing an arterial switch operation (ASO) for Transposition of the Great Arteries (TGA) changes the incidence of major postoperative adverse events (AEs).

Major postoperative AEs include cardiac arrest, emergency chest opening, use of ECMO (machine that acts as an artificial heart and lung during surgery), and death.

Participants will be randomised to receive oxygen plus nitric oxide (intervention arm) or oxygen without nitric oxide (control arm) during CPB.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Murdoch Childrens Research Institute; Warwick Butt
• Treatments: Nitric Oxide

Criteria

Inclusion criteria;

Each participant must meet all of the following criteria to be enrolled in this study:

• Infant aged greater than or equal to 36 weeks gestation

• Infants less than 2 years

• Diagnosed with TGA and requiring Arterial Switch Operation

• Consent of parents/guardian.

Exclusion criteria

Potential participants will be excluded if they meet any of the following criteria:

• They have multiple major congenital anomalies (anomalies which affect the infant's life expectancy or health status)

• They have multiple other cardiac abnormalities (with the exception of ASD, VSD or PDA)

• They weigh less than 2.2kgs.

• Prior surgical exposure to cardio-pulmonary bypass