Intraoperative Cerebral Autoregulation MonitoringNCT07630129
AUTOREGULATE- NONCARDIAC-COTRENDING
An observational study of Intraoperative Cerebral Autoregulation Monitoring, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to prospectively assess the feasibility and clinical implications of intraoperative real-time cAR monitoring using the Medtronic Cotrending algorithm. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Intraoperative Cerebral Autoregulation Monitoring
- What is being tested?
- Data collection
- How many people
- 256 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Dec 2025to 31 Dec 2026
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The substudy data originate from AUTOREGULATE-NONCARDIAC (NCT05336864) and will encompass all patients monitored intraoperatively with the Medtronic INVOS(TM) NIRS device, i.e. all patients included at the University Hospital Basel study center. The substudy population demographics are representative of the AUTOREGULATE-NONCARDIAC study population.
Who may be able to join
- All patients included in AUTOREGULATE-NONCARDIAC at the University Hospital Basel study center with the Medtronic INVOS(TM) near-infrared spectroscopy (NIRS) device.
Who cannot join
- No intraoperative data collected
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
Basel, 4031
About this study
Official title: Feasibility and Clinical Implications of Real-time Cerebral Autoregulation Monitoring in Major Noncardiac Surgery With the Medtronic Cotrending Algorithm (AUTOREGULATE- NONCARDIAC-COTRENDING)
This study is to prospectively assess the feasibility and clinical implications of intraoperative real-time cAR monitoring using the Medtronic Cotrending algorithm.
Read the detailed description
Intraoperative hypotension during noncardiac surgery is strongly associated with postoperative organ injury. The AUTOREGULATE-NONCARDIAC study, a multicenter prospective cohort study and precision medicine platform is aiming to investigate the feasibility and clinical implications of different approaches of cerebral autoregulation (cAR) monitoring in high-risk patients undergoing major noncardiac surgery (ClinicalTrials.gov NCT05336864). A central shortcoming of the currently used gold standard methodology of cerebral autoregulation monitoring (COx [Cerebral Oximetry Index] methodology) is its necessity for extended periods of monitoring data with sufficient variability, its high failure rate in certain settings, e.g. in noncardiac surgery, and the requirement for expertise in evaluating the generated cerebral autoregulatory curves.
There is a need for novel approaches to cerebral autoregulation monitoring addressing the performance and usability issues of the COx methodology. One potentially promising algorithm is the Medtronic Cotrending algorithm, which in cardiac surgery has shown strong agreement with the COx methodology and provided rapid estimates of cAR state with high uptime and user-friendly visualization of autoregulatory status. However, the Medtronic Cotrending algorithm has never been tested in noncardiac surgery.
This substudy of AUTOREGULATE-NONCARDIAC aims to prospectively assess the feasibility and clinical implications of intraoperative real-time cAR monitoring using the Medtronic Cotrending algorithm.
- Being tested
- Data collection
- Keywords
- Noncardiac surgery, Cerebral autoregulation (cAR), Cerebral Oximetry Index (COx), Cerebral lower limit of autoregulation (cLLA), Blood pressure (BP), Medtronic Cotrending algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection from a subset of patients from AUTOREGULATE-NONCARDIAC study (ClinicalTrials.gov NCT05336864) who underwent intraoperative cerebral oximetry monitoring with the Medtronic INVOSTM near-infrared spectroscopy (NIRS) device. Analysis of data will be offline, i.e. following conclusion of surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical feasibility of using the Medtronic Cotrending algorithm
Specifically, it will be determined:
- Success rate of cerebral lower limit of autoregulation (cLLA) determination: proportion of patients in study cohort in whom cerebral autoregulatory parameters could be determined
- Intraoperative uptime: percentage of intraoperative time during which presumed valid and actionable estimates of cerebral autoregulatory parameters were delivered
- Time to first estimate of cerebral autoregulatory parameters: Elapsed intraoperative time to first presumed valid estimates of cerebral autoregulatory parameters
- Sensitivity to external factors: Sensitivity of the algorithm to known confounders and determinants of cerebral autoregulatory function, e.g. changes in gas exchange, administration of vasopressors, skin pigmentation.
- Sensitivity to data artefacts: Sensitivity of the algorithm to artefacts in data (e.g. in BP or rSO2 signals).
Measured: one time assessment at study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start17 Dec 2025
- Primary completion29 Jan 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Cerebral Autoregulation MonitoringStudies of the same condition, open and under way.
- 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
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick M. Wanner, Principal investigator, Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630129
- Sponsor's protocol ID
- 2025-02371; am26Wanner
- Other IDs
- 2025
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Clinical Implications of Real-time Cerebral Autoregulation Monitoring in Major Noncardiac Surgery With the Medtronic Cotrending Algorithm (AUTOREGULATE- NONCARDIAC-COTRENDING)
- ClinicalTrials.gov ID
- NCT07630129
- Acronym / sponsor ID
- 2025-02371; am26Wanner
- Keywords
- Noncardiac surgery, Cerebral autoregulation (cAR), Cerebral Oximetry Index (COx), Cerebral lower limit of autoregulation (cLLA), Blood pressure (BP), Medtronic Cotrending algorithm
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jun 2026 (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 study is to prospectively assess the feasibility and clinical implications of intraoperative real-time cAR monitoring using the Medtronic Cotrending algorithm.
Detailed description
Intraoperative hypotension during noncardiac surgery is strongly associated with postoperative organ injury. The AUTOREGULATE-NONCARDIAC study, a multicenter prospective cohort study and precision medicine platform is aiming to investigate the feasibility and clinical implications of different approaches of cerebral autoregulation (cAR) monitoring in high-risk patients undergoing major noncardiac surgery (ClinicalTrials.gov NCT05336864). A central shortcoming of the currently used gold standard methodology of cerebral autoregulation monitoring (COx [Cerebral Oximetry Index] methodology) is its necessity for extended periods of monitoring data with sufficient variability, its high failure rate in certain settings, e.g. in noncardiac surgery, and the requirement for expertise in evaluating the generated cerebral autoregulatory curves.
There is a need for novel approaches to cerebral autoregulation monitoring addressing the performance and usability issues of the COx methodology. One potentially promising algorithm is the Medtronic Cotrending algorithm, which in cardiac surgery has shown strong agreement with the COx methodology and provided rapid estimates of cAR state with high uptime and user-friendly visualization of autoregulatory status. However, the Medtronic Cotrending algorithm has never been tested in noncardiac surgery.
This substudy of AUTOREGULATE-NONCARDIAC aims to prospectively assess the feasibility and clinical implications of intraoperative real-time cAR monitoring using the Medtronic Cotrending algorithm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The substudy data originate from AUTOREGULATE-NONCARDIAC (NCT05336864) and will encompass all patients monitored intraoperatively with the Medtronic INVOS(TM) NIRS device, i.e. all patients included at the University Hospital Basel study center. The substudy population demographics are representative of the AUTOREGULATE-NONCARDIAC study population.
Key inclusion criteria (1 listed)
- All patients included in AUTOREGULATE-NONCARDIAC at the University Hospital Basel study center with the Medtronic INVOS(TM) near-infrared spectroscopy (NIRS) device.
Key exclusion criteria (1 listed)
- No intraoperative data collected
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 |
|---|---|---|
| Data collectionData collection from a subset of patients from AUTOREGULATE-NONCARDIAC study (ClinicalTrials.gov NCT05336864) who underwent intraoperative cerebral oximetry monitoring with the Medtronic INVOSTM near-infrared spectroscopy (NIRS) device. Analysis of data will be offline, i.e. following conclusion of surgery. | Other | – |
Primary outcome
Technical feasibility of using the Medtronic Cotrending algorithm
Time frame: one time assessment at study end
Specifically, it will be determined: * Success rate of cerebral lower limit of autoregulation (cLLA) determination: proportion of patients in study cohort in whom cerebral autoregulatory parameters could be determined * Intraoperative uptime: percentage of intraoperative time during which presumed valid and actionable estimates of cerebral autoregulatory parameters were delivered * Time to first estimate of cerebral autoregulatory parameters: Elapsed intraoperative time to first presumed valid estimates of cerebral autoregulatory parameters * Sensitivity to external factors: Sensitivity of the algorithm to known confounders and determinants of cerebral autoregulatory function, e.g. changes in gas exchange, administration of vasopressors, skin pigmentation. * Sensitivity to data artefacts: Sensitivity of the algorithm to artefacts in data (e.g. in BP or rSO2 signals).
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 5 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Intraoperative Cerebral Autoregulation Monitoring
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
RecruitingObservational study
CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State
Perioperative/Postoperative Complications, Postoperative Cognitive Dysfunction
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. This study is not recruiting at the moment.
Patrick M. Wanner principal investigator
Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Cerebral Autoregulation Monitoring, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 5 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 1 site in Switzerland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical feasibility of using the Medtronic Cotrending algorithm (time frame: one time assessment at study end). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2026.