RECOGNISE
Research type
Research Study
Full title
Routine usE of Cerebral Oximetry monitorinG iN cardIac SurgEry. A Randomised Controlled Single Centre Study to evaluate the use of neuromonitoring to identify and reduce postoperative complications.
IRAS ID
212210
Contact name
Roberto Mosca
Contact email
Sponsor organisation
UHSM (Wythenshawe Hospital)
Duration of Study in the UK
1 years, 3 months, 25 days
Research summary
Cardiac surgery involving cardiopulmonary bypass carries with it a significant incidence of delirium and cerebrovascular accident. The study aims to see if an additional monitoring device called a cerebral oximeter, which uses Near infra red spectroscopy (NIRS)and alerts the anaesthetist to the use of a structured algorithm can improve outcomes for patients who are assessed as being at medium risk of experiencing confusion or other complications following cardiac surgery. The cerebral oximiter is already currently used within UHSM as part of standard care at the discretion of the anaesthetist, however currently only in higher risk patients. NIRS is used for the assessment of bifrontal regional cortical oxygen saturation and has been shown to have a relationship with peri operative stroke and delirium. It is also possible that , by using the brain as the index organ, the NIRS could identify a decrease in oxygen saturation in other organs – that is when the brain has a deficit of oxygen supply it is reasonable to expect that other organs, for example the kidneys, also do. In this case increasing the oxygen supply to the brain would also increase the oxygen supply to other organs and prevent their dysfunction. The study will randomise participants to a control group where the cerebral oximeter is used but with the device in a mode where the data is recorded, but alters and screen is disabled to record comparison data, whereas the interventional group will have full use of the device, to alert the anaesthetist to begin using the algorithm. The elements of the algorihtm are currently used within standard care, but would be implemented at the discretion of the anaesthetist, rather than being alerted to do so. Oxygen levels are recorded hourly as part of standard clinical care for all participants.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
17/NW/0504
Date of REC Opinion
19 Sep 2017
REC opinion
Favourable Opinion