Autoflow
Research type
Research Study
Full title
Data collection for the development of algorithms to predict the limits of autoregulation for cerebral and renal blood flow during major surgery with continuous invasive and non-invasive blood pressure measurements.
IRAS ID
290456
Contact name
Simon Davies
Contact email
Sponsor organisation
York Teaching Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 7 days
Research summary
We will collect data about blood pressure and tissue oxygen levels, and relate the two measurements. This will help us to develop an algorithm to predict if oxygen levels in the brain are likely to become low in the future. The brain regulates its own blood flow to ensure it gets all the oxygen it needs - however it can only do this when the blood pressure is between certain levels and, outside of these protective levels, brain blood flow is directly dependent on the blood pressure. Being able to predict the limit of brain blood flow autoregulation is important because low brain oxygen levels are associated with complications after surgery.
We think the data collected in this study will tell us if it is technically possible in the future to predict whether or not oxygen levels are going to be low in the brain before it happens. If clinicians get prior warning of these events, then they can potentially treat and avoid low brain oxygen levels.
We will recruit 100 patients undergoing planned major surgery as they will have the necessary monitoring already in place. To these monitors, we will add some sensors that emit a special type of light to look at brain - and other - tissue oxygen levels, as well as a finger cuff that measures blood pressure in a different way to normal.
We will conduct the study in hospital during the patient's surgery and their participation in the study will be for the duration of that surgery. There is no potential benefit for participants and the only potential harm is the extremely low possibility of burns from the sensor or pressure injuries from the finger cuff.
The study is funded by Edwards Lifesciences, and we will recruit in the UK and in the Netherlands.
REC name
HSC REC B
REC reference
20/NI/0166
Date of REC Opinion
23 Nov 2020
REC opinion
Further Information Favourable Opinion