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Association of Intraoperative Blood Pressure Excursions Below Cerebral Autoregulatory Boundaries With Organ Injury Following Major Noncardiac Surgery

NCT05336864 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 650

Last updated 2025-07-17

No results posted yet for this study

Summary

The aim of study is to investigate the clinical relevance of blood pressure (BP) excursions below cerebral autoregulatory boundaries in major noncardiac surgery. The study seeks to establish a precedent for a personalized definition of intraoperative arterial hypotension based on non-invasive tissue oxygenation measurements. The feasibility of NIRS-based autoregulation monitoring in major noncardiac surgery and the prognostic relevance of BP excursions below the NIRS-derived lower limit of autoregulation (LLA) with regard to major cardiovascular, renal and neurological complications will be investigated.

Conditions

  • Intraoperative Arterial Hypotension

Interventions

OTHER

Non-invasive cerebral oximetry monitoring

Main study (all patients): Continuous bilateral frontal cerebral near-infrared spectroscopy (NIRS) monitoring will be performed in all patients for the duration of general anesthesia. Intraoperative parameters including NIRS and invasive blood pressure will be collected and recorded in real-time using the software ICM+. Postoperative hemodynamics substudy (facultative): Cerebral NIRS monitoring will be continued postoperatively in a subset of patients being admitted to the ICU.

OTHER

additional perioperative blood sampling

Main study (all patients): Creatinine, high-sensitivity troponin (T hs-cTnT), Growth/Differentiation Factor-15 (GDF-15), Hemoglobin Neurological injury substudy (facultative): Neurofilament Light Chain (NFL) and C-reactive protein (CRP)

OTHER

clinical & telephone assessments

Main study (all patients): Telephone follow-up (1-year outcomes).

OTHER

Non-invasive somatic oximetry monitoring

Tissue perfusion substudy (facultative): Continuous somatic NIRS monitoring of an extremity (i.e. on skin of leg or arm) will be performed intraoperatively and postoperatively in a subset of patients being admitted postoperatively to the ICU.

OTHER

Processed electroencephalogram (pEEG) monitoring

Processed EEG substudy to explore the relationship between processed EEG-derived depth of anesthesia metrics and cerebral autoregulatory function.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Patrick M Wanner, Dr. med. · Clinic for Anaesthesia, University Hospital Basel

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2026-01-31
Completion
2027-01-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05336864 on ClinicalTrials.gov