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Clinical Trials/NCT07630129
NCT07630129Active, not recruitingNot Applicable

Feasibility and Clinical Implications of Real-time Cerebral Autoregulation Monitoring in Major Noncardiac Surgery With the Medtronic Cotrending Algorithm (AUTOREGULATE- NONCARDIAC-COTRENDING)

University Hospital, Basel, Switzerland1 site in 1 country256 target enrollmentStarted: December 17, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
256
Locations
1

Study Overview

Brief Summary

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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
45 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor
University Hospital, Basel, Switzerland
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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