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Aim oft he study is to compare two different devices for cerebral oximetry (FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA) in patients undergoing surgical carotid thrombendarterectomy (cTEA) with crossclamped internal carotid artery (ACI). All procedures will be performed in regional anesthesia, therefore the patients will be awake and direct neurological examination during the procedure will be possible, giving information how the drop in cerebral saturation (measured with INVOS and FORESIGHT both on the same patient) correlates with any clinical symptoms.
We expect to see a difference in the total drop and in the delay of the drop of cerebral oxygen saturation, making it possible to detect varieties in specificity and sensitivity of both devices compared to neurologic examination in the awake patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all patients | All patients will be measured throughout the procedure with both devices. There no further separation into groups as both sensors can be placed on the same patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRS - Near-infrared spectroscopy | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| absolute tissue saturation (StO2) measured with(FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA) | The drop in StO2 will be compared to the occurrence of any clinical i.e. neurological symptoms during clamping o the carotid artery while cTEA is performed. | During the surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| NSE | Biomarker for ischemic brain damage. Serum levels neuron specific enolase (NSE) increases in patients during the acute phase of brain damage. Therefore it is measured to find out whether or not there is correlation to a low oxygen saturation without neurological symptoms during cTEA. | Before and after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic parameters | Blood pressure | During the surgical procedure |
| Hemodynamic parameters | Peripheral oxygen saturation | During the surgical procedure |
Inclusion Criteria:
- Patients with electively scheduled carotid thrombendarterectomy in regional anesthesia
Exclusion Criteria:
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All patients scheduled for CTEA at the University Hospital Salzburg
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Koköfer, M.D. | Contact | 0043-662 4482 | 58664 | a.kokoefer@salk.at |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Koköfer, M.D. | UK für Anästhesiologie, LKH Salzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH University Clinic Salzburg | Recruiting | Salzburg | State of Salzburg | 5020 | Austria |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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S100B and NSE blood samples taken twice, before and after the surgical procedure
| S100B |
Biomarker for ischemic brain damage. Serum levels of S100B increases in patients during the acute phase of brain damage. Therefore it is measured to find out whether or not there is correlation to a low oxygen saturation without neurological symptoms during cTEA. |
| Before and after the surgery |
| Hemodynamic parameters | ECG | During the surgical procedure |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |