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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.
Adverse neurological events include perioperative neurocognitive disorders and stroke and remain one of the major risks after cardiac surgery. A lack of a comprehensive knowledge of their causes and neuroprotective strategies has hindered the development of strategies to effectively reduce these complications. Against this background, this research project will take three approaches. First, non-invasive, personalised cerebral autoregulation-oriented blood pressure monitoring aims to reduce complications by uncovering blood pressure targets tailored to individual characteristics. In parallel, establishing biological associations between adverse neurological outcomes, brain injury biomarkers and genetic studies are complementary strategies that make a move to a proactive patient-tailored paradigm, ultimately understanding the mechanisms and improving patient outcomes, patient safety and quality of life.
Therefore, this international, multicentre prospective cohort study will assess whether perioperative duration and magnitude of MAP outside of an individual's CA limits using NIRS and TCD are associated with adverse neurological events. It is to investigate whether patients with a higher burden of cerebral haemodynamic insults, defined by the duration and magnitude spent outside of an individual's CA limits based on NIRS and/or TCD, have an increased incidence of postoperative delirium (POD), stroke or cognitive decline. Biological associations between adverse neurological outcomes, the role of brain injury serum biomarkers will be explored. Genetic studies will be conducted on participants who give written informed consent for these further investigations.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative data collection | Other | 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 | Diagnostic Test | Intraoperatively, NIRS data will be collected and recorded in real-time. | ||
| Intraoperative TCD | Diagnostic Test | Intraoperatively, TCD data will be collected and recorded in real-time. | ||
| Intraoperative invasive MAP | Diagnostic Test | Intraoperatively, invasive arterial blood pressure data will be collected and recorded in real-time. | ||
| Postoperative NIRS |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 3D-CAM to assess postoperative delirium (POD) | Change in 3D-CAM to assess POD. The 3D-CAM rates four diagnostic features, including acute onset and fluctuating course, inattention, disorganized thinking, and altered level of consciousness. Delirium scored as 'present' (1) or 'absent' (0) based on question responses. | Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier) |
| Change in Confusion Assessment Method for the ICU (CAM-ICU) to assess postoperative delirium (POD) | CAM-ICU is an adaptation of the CAM to be usable by clinicians to screen for delirium in the intensive care unit setting designed for intubated patients. The CAM-ICU utilizes the CAM diagnostic algorithm. There are four core features including acute onset or fluctuating course, inattention, disorganized thinking, and altered level of consciousness rated with 8 items. 3 of the 4 features must be present for CAM-ICU to be considered positive, according to the original CAM algorithm. Items are rated absent/present base on specific thresholds. | Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in modified National Institutes of Health Stroke Scale (mNIHSS) | Change in mNIHSS to assess postoperative clinical stroke | Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier) |
| Change in Montreal Cognitive Assessment (MoCA) |
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Inclusion Criteria:
Exclusion Criteria:
Participants who undergo cardiac surgery under minimal extracorporeal circulation will also be excluded.
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The target population consists of in-hospital patients undergoing cardiac surgery at three centres in two European countries. Patients will be screened for eligibility. Therefore, consecutive ongoing recruitment of patients fulfilling the in- and exclusion criteria will take place during daily clinical practice at the participating hospitals.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nuno V. Gomes, MD | Contact | +41 61 328 64 46 | nuno.gomes@usb.ch | |
| Luzius A. Steiner, MD, PhD | Contact | + 41 61 328 64 74 | luzius.steiner@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Nuno V. Gomes, MD | Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel | Completed | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41857828 | Derived | Gomes NV, Edgar-Whelan H, Beqiri E, Young J, Schindler C, Gregor M, Erb JM, Siegemund M, Kuhle J, Maleska Maceski A, Needham E, Cichon S, Burger B, Monsch AU, Hasemann W, Wuest A, Fassl J, Kaiser HA, Hight D, Levis A, Gunsch D, Menon DK, Czosnyka M, Smielewski P, Klein AA, Dell-Kuster S, Steiner LA. PRECISION study: impact of personalised cardiac anaesthesia and cerebral autoregulation on neurological outcomes in patients undergoing cardiac surgery - protocol for an international, multicentre, prospective cohort study. BMJ Open. 2026 Mar 18;16(3):e115288. doi: 10.1136/bmjopen-2025-115288. |
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The remaining biological materials (non-genetic and genetic) will be stored in biobanks in accordance with local technical and legal standards for 10 years after publication of this study for future research projects that have not yet been defined in more detail and for which a ethical approval will be attained.
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 | Other | 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 | Diagnostic Test | 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 | Diagnostic Test | A blood sample for the genetic study will be obtained preoperatively. |
Change in MoCA to assess postoperative neurocognitive disorder |
| Between 6 weeks and 12 weeks, and up to 12 months after surgery |
| Postoperative increase in serum creatinine | Postoperative increase in serum creatinine of ≥ 26.5 μmol/l (≥ 0.3 mg/dl) within 48 hours or ≥ 1.5 times of baseline to assess acute kidney injury | Within 48 hours after surgery |
| De novo renal replacement therapy | De novo renal replacement therapy | Within postoperative day 7 (or up to discharge) |
| Major morbidity | Major morbidity as defined by the Society of Thoracic Surgeons as having at least one of the following adverse outcomes: stroke, surgical re-exploration for any cardiac reason (bleeding, coronary graft occlusion, valve dysfunction, and others), renal failure, deep sternal wound infection/mediastinitis, and prolonged ventilation (> 24 hours) | Within postoperative day 7 (or up to discharge) |
| Intensive care unit (ICU) stay (in hours) | Number of hours in ICU | From day of surgery until discharge from ICU (approx. 1 day) |
| Length of hospital stay (in days) | Number of days in hospital | From day of surgery until discharge from hospital (approx. 7 days) |
| Perioperative mortality | Perioperative mortality, defined as any in-hospital or postdischarge death within 30 days after surgery, regardless of cause, or any death occurring during the hospitalisation, even after 30 days | Within within 30 days after surgery |
| Change in brain injury biomarker panel | The serum biomarker panel consists of at least four markers of neurological injury: glial fibrillary acidic protein (GFAP), neurofilament light (NfL), total tau, and ubiquitin-carboxy-terminal hydrolase-L1 (UCH-L1). | At preoperative screening; at day of surgery; at postoperative day 1, 2 and 6 (or hospital discharge, whichever occurs first); between 6 weeks and 12 weeks after surgery |
| Inselspital, Bern University Hospital | Recruiting | Bern | 3010 | Switzerland |
|
| Cambridge University Hospitals and Brain Physics Lab | Completed | Cambridge | CB2 0QQ | United Kingdom |
| Royal Papworth Hospital, Department of Anaesthesia and Intensive Care | Completed | Cambridge | CB2 0QQ | United Kingdom |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D000079690 | Postoperative Cognitive Complications |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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