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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction; Postoperative Stroke
• Intervention / Treatment: Diagnostic test: Intraoperative NIRS; Diagnostic test: Intraoperative TCD; Diagnostic test: Intraoperative invasive MAP; Diagnostic test: Postoperative NIRS; Diagnostic test: Collection of blood sample for genetic study; Other: Preoperative data collection; Other: Postoperative data collection; Diagnostic test: Collection of serum biomarker panel

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Nuno V. Gomes, MD; Phone Number: +41 61 328 64 46; Email: nuno.gomes@usb.ch
• Study Contact Backup: Name: Luzius A. Steiner, MD, PhD; Phone Number: + 41 61 328 64 74; Email: luzius.steiner@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
    • Contact: Nuno V. Gomes, MD; Phone Number: +41 61 328 64 46; Email: nuno.gomes@usb.ch
    • Contact: Luzius A. Steiner, MD, PhD; Phone Number: + 41 61 328 64 74; Email: luzius.steiner@usb.ch
    • Principal Investigator: Nuno V. Gomes, MD
    • Sub-Investigator: Salome Dell-Kuster, MD, MSc
    • Sub-Investigator: Luzius A. Steiner, MD, PhD
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital, Bern University Hospital
    • Contact: Dominik Günsch, MD; Phone Number: +41 31 632 03 77; Email: dominik.guensch@insel.ch
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Royal Papworth Hospital, Department of Anaesthesia and Intensive Care
    • Principal Investigator: Andrew Klein, MD
    • Contact: Andrew Klein, MD; Phone Number: +44 1223 639666; Email: andrew.klein@nhs.net
  • Cambridge, United Kingdom, CB2 0QQ
    • Active, not recruiting
    • Cambridge University Hospitals and Brain Physics Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Elective primary or reoperative coronary artery bypass graft and/or valvular and/or ascending aorta surgery requiring cardiopulmonary bypass.

Exclusion Criteria:

• Surgery requiring moderate (28-31.9ºC) or deep (<28ºC) hypothermic circulatory arrest;
• Heart and/or lung transplantation;
• Urgent (within 24 hours) and emergency surgery;
• Inability to follow procedures or insufficient knowledge in English, German or French;
• Inability to give consent.

Participants who undergo cardiac surgery under minimal extracorporeal circulation will also be excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Nuno V. Gomes, MD, Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: cardiac surgery; near-infrared spectroscopy; cerebral autoregulation; postoperative delirium; hypotension; transcranial Doppler; neurological outcomes; postoperative cognitive decline; adverse neurological events; postoperative stroke; personalised cardiac anaesthesia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Cognitive Dysfunction; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Cognitive Complications; Emergence Delirium; Hypotension
• Other Study ID Numbers: 2022-01457; am22Gomes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No