Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery

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.

Conditions

• Postoperative Delirium
• Postoperative Stroke
• Postoperative Cognitive Dysfunction

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Collection of blood sample for genetic study

A blood sample for the genetic study will be obtained preoperatively.

OTHER

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.

DIAGNOSTIC_TEST

Intraoperative NIRS

Intraoperatively, NIRS data will be collected and recorded in real-time.

DIAGNOSTIC_TEST

Intraoperative TCD

Intraoperatively, TCD data will be collected and recorded in real-time.

DIAGNOSTIC_TEST

Intraoperative invasive MAP

Intraoperatively, invasive arterial blood pressure data will be collected and recorded in real-time.

DIAGNOSTIC_TEST

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.

OTHER

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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland

  lead OTHER

Principal Investigators

• Nuno V. Gomes, MD · Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-23

Primary Completion

2026-08-31

Completion

2027-08-31

Countries

• Switzerland
• United Kingdom

Study Locations