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

RecruitingOBSERVATIONAL
Enrollment

650

Participants

Timeline

Start Date

May 20, 2022

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2027

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.

Trial Locations (3)

3010

RECRUITING

Inselspital, Bern University Hospital, Department of Anaesthesiology and Pain Medicine, Bern

4031

RECRUITING

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

9007

RECRUITING

Cantonal Hospital St. Gallen, Division of Perioperative Intensive Care Medicine, Sankt Gallen

All Listed Sponsors
lead

University Hospital, Basel, Switzerland

OTHER