AUTOREGULATE- NONCARDIAC-COTRENDING

NCT07630129 | Active Not Recruiting

• 1 other identifier: 2025-02371; am26Wanner
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to prospectively assess the feasibility and clinical implications of intraoperative real-time cAR monitoring using the Medtronic Cotrending algorithm.

Conditions

Intraoperative Cerebral Autoregulation Monitoring

Keywords

Noncardiac surgery; Cerebral autoregulation (cAR); Cerebral Oximetry Index (COx); Cerebral lower limit of autoregulation (cLLA); Blood pressure (BP); Medtronic Cotrending algorithm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  one time assessment at study end

• Predictability of intraoperative Cotrending-derived boundaries of cerebral autoregulation

  one time assessment at study end

Interventions

Data collection OTHER

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• No intraoperative data collected

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

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

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Patrick M. Wanner

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 5, 2026
• Study Start: December 17, 2025
• Primary Completion: January 29, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)