AUTOREGULATE- NONCARDIAC-COTRENDING

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intraoperative Cerebral Autoregulation Monitoring
• Intervention / Treatment: Other: Data collection

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 Type: Observational
• Enrollment (Actual): 256

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• All patients included in AUTOREGULATE-NONCARDIAC at the University Hospital Basel study center with the Medtronic INVOS(TM) near-infrared spectroscopy (NIRS) device.

Exclusion Criteria:

• No intraoperative data collected

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	one time assessment at study end

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation	Determination of the extent of between-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation.	one time assessment at study end
Within-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation	Determination of the extent of within-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation.	one time assessment at study end
Predictability of intraoperative Cotrending-derived boundaries of cerebral autoregulation	Determination to what extent the intraoperative Cotrending-derived boundaries of cerebral autoregulation can be predicted using preoperative or preinduction blood pressures.	one time assessment at study end
Within-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation	Determination to what extent within-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation can be explained by other intraoperative factors, e.g. CO2 variability.	one time assessment at study end
Association of disturbed intraoperative Cotrending-derived cerebral autoregulatory function with the composite of postoperative organ injury (myocardial injury and/or acute kidney injury) on postoperative days 1-3	Investigation of the association of disturbed intraoperative Cotrending-derived cerebral autoregulatory function with the composite of postoperative organ injury (myocardial injury and/or acute kidney injury) on postoperative days 1-3.	one time assessment at study end
Association of disturbed intraoperative Cotrending-derived cerebral autoregulatory function with the composite of major cardiovascular, renal and neurological complications up to 1 year following surgery	Investigation of the association of disturbed intraoperative Cotrending-derived cerebral autoregulatory function with the composite of major cardiovascular, renal and neurological complications up to 1 year following surgery.	one time assessment at study end

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Patrick M. Wanner, Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Actual): January 29, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Noncardiac surgery; Blood pressure (BP); Cerebral autoregulation (cAR); Cerebral Oximetry Index (COx); Cerebral lower limit of autoregulation (cLLA); Medtronic Cotrending algorithm
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: 2025-02371; am26Wanner

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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