SAFE monitoring
Research type
Research Study
Full title
Surgery on the Aortic arch and Feasibility of EEG (SAFE) monitoring.
IRAS ID
279319
Contact name
Stefano Seri
Contact email
Sponsor organisation
Birmingham Children's Hospital
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Aortic arch repair is a complex surgery on one of the body’s major blood vessels which requires specialised neuroprotective strategies because vessels supplying the brain with blood are temporarily occluded and the heart is stopped whilst the arch is repaired. Reducing the amount of energy the brain needs during the operation via hypothermia protects against the effects of brain damage. The optimal protection occurs during periods where there is no brain activity (also called electrocerebral inactivity/ECI) and this can be recorded via electroencephalography (EEG).
ECI occurs at core body temperatures between 28-12°C. Sixty percent of adults achieve ECI at 18°C (the temperature used by the Birmingham Children’s Hospital) but the time to achieve ECI in children is more variable. Without EEG, multisite temperature monitoring is recommended to ensure adequate brain cooling but ECI and brain temperature cannot be precisely predicted. We think that patients may achieve ECI, and optimal protection, at more moderate levels of hypothermia and a proportion may not which is why we want to record EEG activity during the operation to see if our current management provides the best protection.
In addition, up to 16% of potential study participants develop sub-clinical seizures and the only way to detect these is via EEG. EEG may be able to identify which patients are more likely to require specialized neuroprotection as certain patterns will highlight nervous system abnormalities. Although there is currently insufficient evidence to support routine EEG monitoring for the study population, it is feasible that:
• Preoperative EEG could identify patients at high risk of neurological complications.
• There may be inter-individual variation in the degree of hypothermia required to achieve ECI, and therefore optimal neuroprotection.
• Postoperatively, some patients may develop subclinical seizures which go undetected in the absence of EEG monitoring and are associated with adverse neurological outcome.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0192
Date of REC Opinion
23 Jun 2020
REC opinion
Further Information Favourable Opinion