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| ID | Type | Description | Link |
|---|---|---|---|
| 094579/2015/OTIG | Other Identifier | Health Registration and Training Center Department of Medical Devices |
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The primary endpoint of our study is to determine whether neurological symptoms (aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, changes showed by transcranial Doppler or INVOS monitor is more sensitive regarding the symptoms? Secondary endpoint: the degree of change in the measured parameters after the internal carotid artery is clamped, and if there is any difference between the operated and non-operated sides?
Investigation of blood flow velocity in the middle cerebral artery and oxygen saturation of the brain bilaterally during carotid endarterectomy carried out in local anesthesia in patients with and without neurological symptoms using transcranial Doppler (TCD) and INVOS monitor.
Zoltán Gyöngyösi Study protocol
The primary endpoint of our study is to determine whether neurological symptoms (aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, changes showed by transcranial Doppler or INVOS monitor is more sensitive regarding the symptoms? Secondary endpoint: the degree of change in the measured parameters after the internal carotid artery is clamped, and if there is any difference between the operated and non-operated sides?
Patients and Methods
Outpatient examination, preparation and anesthesia of the patients:
Surgical anesthesia:
Intraoperative measurements:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients without neurological symptoms | carotid endarterectomy patients who dont'have any neurological symptoms after carotid clamping |
| |
| patients with neurological symptoms | carotid endarterectomy patients who have new neurological symptoms after carotid clamping |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial Doppler (TCD) and INVOS monitor | Device | Bilateral transcranial Doppler measurements of the blood flow velocity within the middle cerebral arteries: 1. before local anesthesia, 2. after the onset of local anesthetic, but before skin incision, 3. intraoperatively before clamping the internal carotid artery, 4. one minute after clamping the internal carotid artery, 5. five minutes after clamping the internal carotid artery, 6. fifteen minutes after clamping the internal carotid artery, 7. directly after the restoration of blood flow in the internal carotid artery, 8. postoperatively, 4-6 hours after the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms | (aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms Recording mean arterial flow velocity with each TCD measurement. | 15 month |
| to determine the changes in cerebral O2 saturation in patient with intraoperative neurological symptoms | Recording cerebral saturation (INVOS) with each measurement. | 15 month |
| Measure | Description | Time Frame |
|---|---|---|
| the degree of change in the measured parameters during clamp and declamp after the internal carotid artery is clamped, if there is any difference between the operated and non-operated sides? | Recording mean arterial pressure with each TCD measurement. Recording cerebral saturation (INVOS) with each measurement. | 15 month |
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Inclusion Criteria:
Exclusion Criteria:
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100 patients awaiting carotid artery endarterectomy carried out in regional anesthesia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zoltán Mr Gyöngyösi, Md | Contact | +3630/2883970 | zozman77@gmail.com | |
| Erzsébet Igbonu-nagy, nurse | Contact | +3620/3991551 | nagyboske@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Béla Fülesdi, MD,PhD,DSci | Hungary University of Debrecen Debrecen, Hungary, 4032 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Debrecen | Recruiting | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7655972 | Result | Williams IM, Mead G, Picton AJ, Farrell A, Mortimer AJ, McCollum CN. The influence of contralateral carotid stenosis and occlusion on cerebral oxygen saturation during carotid artery surgery. Eur J Vasc Endovasc Surg. 1995 Aug;10(2):198-206. doi: 10.1016/s1078-5884(05)80112-1. | |
| 23973277 | Result | Pennekamp CW, Immink RV, den Ruijter HM, Kappelle LJ, Bots ML, Buhre WF, Moll FL, de Borst GJ. Near-infrared spectroscopy to indicate selective shunt use during carotid endarterectomy. Eur J Vasc Endovasc Surg. 2013 Oct;46(4):397-403. doi: 10.1016/j.ejvs.2013.07.007. Epub 2013 Aug 21. |
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| University of Debrecen | Enrolling by invitation | Debrecen | 4032 | Hungary |
| ID | Term |
|---|---|
| D017585 | Ultrasonography, Doppler, Transcranial |
| ID | Term |
|---|---|
| D004453 | Echoencephalography |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011859 | Radiography |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |
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