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This study is to prospectively assess the feasibility and clinical implications of intraoperative real-time cAR monitoring using the Medtronic Cotrending algorithm.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical feasibility of using the Medtronic Cotrending algorithm | Specifically, it will be determined:
| one time assessment at study end |
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| Measure | Description | Time Frame |
|---|---|---|
| Between-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation | Determination of the extent of 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 |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Patrick M. Wanner | Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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Determination of the extent of 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 | Determination to what extent the intraoperative Cotrending-derived boundaries of cerebral autoregulation can be predicted using preoperative or preinduction blood pressures. | one time assessment at study end |
| Within-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation | Determination to what extent within-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation can be explained by other intraoperative factors, e.g. CO2 variability. | one time assessment at study end |
| Association of disturbed intraoperative Cotrending-derived cerebral autoregulatory function with the composite of postoperative organ injury (myocardial injury and/or acute kidney injury) on postoperative days 1-3 | Investigation of the association of disturbed intraoperative Cotrending-derived cerebral autoregulatory function with the composite of postoperative organ injury (myocardial injury and/or acute kidney injury) on postoperative days 1-3. | one time assessment at study end |
| Association of disturbed intraoperative Cotrending-derived cerebral autoregulatory function with the composite of major cardiovascular, renal and neurological complications up to 1 year following surgery | Investigation of the association of disturbed intraoperative Cotrending-derived cerebral autoregulatory function with the composite of major cardiovascular, renal and neurological complications up to 1 year following surgery. | one time assessment at study end |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |