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Association of Intraoperative Blood Pressure Excursions Below Cerebral Autoregulatory Boundaries With Organ Injury Following Major Noncardiac Surgery
Sponsor: University Hospital, Basel, Switzerland
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.
Official title: Association of Intraoperative Blood Pressure Excursions Below Cerebral Autoregulatory Boundaries With Organ Injury Following Major Noncardiac Surgery (AUTOREGULATE-NONCARDIAC)
Key Details
Gender
All
Age Range
45 Years - Any
Study Type
OBSERVATIONAL
Enrollment
650
Start Date
2022-05-20
Completion Date
2027-01
Last Updated
2025-07-17
Healthy Volunteers
No
Conditions
Interventions
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.
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)
clinical & telephone assessments
Main study (all patients): Telephone follow-up (1-year outcomes).
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.
Processed electroencephalogram (pEEG) monitoring
Processed EEG substudy to explore the relationship between processed EEG-derived depth of anesthesia metrics and cerebral autoregulatory function.
Locations (3)
University Hospital Basel, Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy
Basel, Switzerland
Inselspital, Bern University Hospital, Department of Anaesthesiology and Pain Medicine
Bern, Switzerland
Cantonal Hospital St. Gallen, Division of Perioperative Intensive Care Medicine
Sankt Gallen, Switzerland