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Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery
Sponsor: University Hospital, Basel, Switzerland
Summary
This international, multicentre prospective cohort study will assess whether perioperative duration and magnitude of mean arterial pressure (MAP) outside of an individual's cerebral autoregulation (CA) limits using near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are associated with adverse neurological events. It is to investigate whether patients with a higher burden of cerebral haemodynamic insults have an increased incidence or poorer neurological outcomes. Associations between neurologic outcomes, neurobiomarkers and genetic tests will be explored.
Official title: Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery (PRECISION)
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2023-01-23
Completion Date
2027-08
Last Updated
2026-01-28
Healthy Volunteers
No
Interventions
Preoperative data collection
Preoperatively, patients will be assessed with Montreal Cognitive Assessment (MoCA), Geriatric Depression Scale (GDS), Clinical Frailty Scale, 3-minute Diagnostic interview for Confusion Assessment Method-defined delirium (3D-CAM, incl. severity score), modified National Institutes of Health Stroke Scale (mNIHSS), and hand grip strength measurement (using a hand dynamometer) to establish a baseline measurement of the physical, cognitive and mental status.
Intraoperative NIRS
Intraoperatively, NIRS data will be collected and recorded in real-time.
Intraoperative TCD
Intraoperatively, TCD data will be collected and recorded in real-time.
Intraoperative invasive MAP
Intraoperatively, invasive arterial blood pressure data will be collected and recorded in real-time.
Postoperative NIRS
Postoperatively, NIRS monitoring will be continued in the ICU after the surgery until (i) endotracheal extubation, or (ii) for the first 24 hours or (iii) until emergency re-operation, whichever occurs first.
Postoperative data collection
Postoperatively patients will be evaluated for POD with 3D-CAM or CAM-ICU and for clinical stroke with mNIHSS. Postoperative neurocognitive disorders will be assessed using MoCA.
Collection of serum biomarker panel
The serum biomarker panel will consist, at least, of four markers of neurological injury glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL), total tau and ubiquitin-carboxy-terminal hydrolase-L1 (UCH-L1). Blood samples will be obtained preoperatively, after ICU admission, on postoperative day 1, 2, 6 (or hospital discharge, whichever occurs first) and between 6 and 12 weeks after surgery.
Collection of blood sample for genetic study
A blood sample for the genetic study will be obtained preoperatively.
Locations (4)
Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
Basel, Switzerland
Inselspital, Bern University Hospital
Bern, Switzerland
Cambridge University Hospitals and Brain Physics Lab
Cambridge, United Kingdom
Royal Papworth Hospital, Department of Anaesthesia and Intensive Care
Cambridge, United Kingdom