Carotid Thrombendarterectomy, Cerebral Oxygenation, NIRS, Regional Anesthesia
Conditions
Brief summary
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.
Interventions
DEVICENIRS - Near-infrared spectroscopy
Sponsors
Salzburger Landeskliniken
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patients with electively scheduled carotid thrombendarterectomy in regional anesthesia
Exclusion criteria
* refusing participation * age \<18 years * pregnancy * any contraindication to regional anesthesia or the use of NIRS * participation in any other study affecting the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| absolute tissue saturation (StO2) measured with(FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA) | During the surgical procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NSE | Before and after the surgery | 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. |
| S100B | Before and after the surgery | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic parameters | During the surgical procedure | Blood pressure |
Countries
Austria
Contacts
Primary ContactAndreas Koköfer, M.D.
Outcome results
None listed