Postoperative DeliriumPRECISIONNCT05595954
Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery
An observational study of Postoperative Delirium and Postoperative Stroke, run by University Hospital, Basel, Switzerland at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium, Postoperative Stroke, Postoperative Cognitive Dysfunction
- What is being tested?
- Preoperative data collection, Intraoperative NIRS and Intraoperative TCD
- How many people
- 500 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Jan 2023to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Elective primary or reoperative coronary artery bypass graft and/or valvular and/or ascending aorta surgery requiring cardiopulmonary bypass.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Switzerland2 sites, 1 recruiting
- Completed
Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
Basel, 4031
- Recruiting
Inselspital, Bern University Hospital
Bern, 3010
Dominik Günsch, MD, +41 31 632 03 77, dominik.guensch@insel.ch
United Kingdom2 sites
- Completed
Cambridge University Hospitals and Brain Physics Lab
Cambridge, CB2 0QQ
- Completed
Royal Papworth Hospital, Department of Anaesthesia and Intensive Care
Cambridge, CB2 0QQ
About this study
Official title: 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.
Read the 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.
- Being tested
- Preoperative data collection, Intraoperative NIRS, Intraoperative TCD, Intraoperative invasive MAP, Postoperative NIRS
- Keywords
- cerebral autoregulation, hypotension, neurological outcomes, adverse neurological events, postoperative delirium, postoperative stroke, postoperative cognitive decline, personalised cardiac anaesthesia, cardiac surgery, near-infrared spectroscopy, transcranial Doppler
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative data collectionOther
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 NIRSDiagnostic test
Intraoperatively, NIRS data will be collected and recorded in real-time.
Intraoperative TCDDiagnostic test
Intraoperatively, TCD data will be collected and recorded in real-time.
Intraoperative invasive MAPDiagnostic test
Intraoperatively, invasive arterial blood pressure data will be collected and recorded in real-time.
Postoperative NIRSDiagnostic test
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 collectionOther
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 panelDiagnostic 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 studyDiagnostic test
A blood sample for the genetic study will be obtained preoperatively.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)
Secondary outcomes (9)
Change in modified National Institutes of Health Stroke Scale (mNIHSS)
Change in mNIHSS to assess postoperative clinical stroke
Measured: 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
Measured: 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
Measured: Within 48 hours after surgery
De novo renal replacement therapy
De novo renal replacement therapy
Measured: 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)
Measured: Within postoperative day 7 (or up to discharge)
Intensive care unit (ICU) stay (in hours)
Number of hours in ICU
Measured: From day of surgery until discharge from ICU (approx. 1 day)
Length of hospital stay (in days)
Number of days in hospital
Measured: 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
Measured: 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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start23 Jan 2023
- Primary completion4 May 2026
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nuno V. Gomes, MD, Principal investigator, Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595954
- Sponsor's protocol ID
- 2022-01457; am22Gomes
- Acronym
- PRECISION
- Status last verified
- Jun 2026
- First submitted
- 18 Oct 2022
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41857828
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery (PRECISION)
- ClinicalTrials.gov ID
- NCT05595954
- Acronym / sponsor ID
- PRECISION / 2022-01457; am22Gomes
- Keywords
- cerebral autoregulation, hypotension, neurological outcomes, adverse neurological events, postoperative delirium, postoperative stroke, postoperative cognitive decline, personalised cardiac anaesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- Elective primary or reoperative coronary artery bypass graft and/or valvular and/or ascending aorta surgery requiring cardiopulmonary bypass.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative data collectionPreoperatively, 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. | Other | – |
| Intraoperative NIRSIntraoperatively, NIRS data will be collected and recorded in real-time. | Diagnostic test | – |
| Intraoperative TCDIntraoperatively, TCD data will be collected and recorded in real-time. | Diagnostic test | – |
| Intraoperative invasive MAPIntraoperatively, invasive arterial blood pressure data will be collected and recorded in real-time. | Diagnostic test | – |
| Postoperative NIRSPostoperatively, 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. | Diagnostic test | – |
| Postoperative data collectionPostoperatively 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. | Other | – |
| Collection of serum biomarker panelThe 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 studyA blood sample for the genetic study will be obtained preoperatively. | Diagnostic test | – |
Primary outcome
Change in 3D-CAM to assess postoperative delirium (POD)
Time frame: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)
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.
Change in Confusion Assessment Method for the ICU (CAM-ICU) to assess postoperative delirium (POD)
Time frame: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)
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.
9 secondary outcomes
Change in modified National Institutes of Health Stroke Scale (mNIHSS)
Time frame: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)
Change in Montreal Cognitive Assessment (MoCA)
Time frame: Between 6 weeks and 12 weeks, and up to 12 months after surgery
Postoperative increase in serum creatinine
Time frame: Within 48 hours after surgery
De novo renal replacement therapy
Time frame: Within postoperative day 7 (or up to discharge)
Major morbidity
Time frame: Within postoperative day 7 (or up to discharge)
Intensive care unit (ICU) stay (in hours)
Time frame: From day of surgery until discharge from ICU (approx. 1 day)
Length of hospital stay (in days)
Time frame: From day of surgery until discharge from hospital (approx. 7 days)
Perioperative mortality
Time frame: Within within 30 days after surgery
Change in brain injury biomarker panel
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Derived from this study: PubMed 41857828Gomes 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.
- Protocol publication, BMJ Open, 2026Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nuno V. Gomes, MD principal investigator
Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium and Postoperative Stroke, run by University Hospital, Basel, Switzerland at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nuno V. Gomes, MD (+41 61 328 64 46, nuno.gomes@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 3D-CAM to assess postoperative delirium (POD) (time frame: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05595954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.