Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-02-01 @ 1:01 PM
Study NCT ID:
NCT02665104
Status:
UNKNOWN
Last Update Posted:
2017-03-13
First Post:
2016-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Middle Cerebral Artery Velocity and Oxygen Saturation of the Brain During Carotid Endarterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017585', 'term': 'Ultrasonography, Doppler, Transcranial'}], 'ancestors': [{'id': 'D004453', 'term': 'Echoencephalography'}, {'id': 'D009485', 'term': 'Neuroradiography'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-08', 'studyFirstSubmitDate': '2016-01-13', 'studyFirstSubmitQcDate': '2016-01-22', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms', 'timeFrame': '15 month', 'description': '(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\n\nRecording mean arterial flow velocity with each TCD measurement.'}, {'measure': 'to determine the changes in cerebral O2 saturation in patient with intraoperative neurological symptoms', 'timeFrame': '15 month', 'description': 'Recording cerebral saturation (INVOS) with each measurement.'}], 'secondaryOutcomes': [{'measure': '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?', 'timeFrame': '15 month', 'description': 'Recording mean arterial pressure with each TCD measurement. Recording cerebral saturation (INVOS) with each measurement.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cerebral oxygen saturation', 'TCD', 'NIRS', 'Carotid endarterectomy'], 'conditions': ['Cerebral Oxygen Saturation,MCA Velocity,Intraoperative Neurological Symptoms During Carotid Endarterectomy']}, 'referencesModule': {'references': [{'pmid': '7655972', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23973277', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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?', 'detailedDescription': "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.\n\nZoltán Gyöngyösi Study protocol\n\nThe 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?\n\nPatients and Methods\n\nOutpatient examination, preparation and anesthesia of the patients:\n\n* ECG test\n* Echocardiography, if it is necessary due to the cardial status of the patient.\n* Indication of surgical intervention provided by the cerebrovascular outpatient clinic, with attached carotid ultrasound and angiography results.\n\nSurgical anesthesia:\n\n* Superficial and deep cervical block with 3.75% ropivacaine (50ml ropivacaine 3.75%) (incase of allergy bupivacaine should be used)\n* Securing venous catheter, infusion of Lactated-Ringer or Voluven solution.\n* In case of pain topical administration of Lidocaine by the surgeon, intravenous administration of 25-50ug Fentanyl or 1 vial of Algopyrin.\n\nIntraoperative measurements:\n\n* 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.\n* Recording mean arterial pressure with each TCD measurement.\n* Recording cerebral saturation (INVOS) with each TCD measurement.\n* Recording any anti-hypertensive therapy in the postoperative phase.\n* Recording heart rate.\n* Recording arterial oxygen saturation.\n* Recording the patients' neurological status with each TCD measurement and continuous neurological monitoring while the internal carotid artery is clamped."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '100 patients awaiting carotid artery endarterectomy carried out in regional anesthesia.\n\n* Age: patients over 18 years.\n* Gender: both female and male patients are included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 100 patients awaiting carotid artery endarterectomy carried out in regional anesthesia.\n* Age: patients over 18 years.\n* Gender: both female and male patients are included in the study.\n* Medical equipment: venous catheter, arterial catheter for invasive blood pressure monitoring.\n* Bilateral continuous measurement of the middle cerebral arteries with Transcranial Doppler.\n* Bilateral continuous measurement of the cerebral saturation with INVOS monitor.\n\nExclusion Criteria:\n\n* Allergy to ropivacaine, bupivacaine.\n* Patients who does not consent to the awake surgery or does not sign the informed consent of the study.\n* If the patient is either psychologically or neurologically unsuitable for the awake surgery.'}, 'identificationModule': {'nctId': 'NCT02665104', 'briefTitle': 'Middle Cerebral Artery Velocity and Oxygen Saturation of the Brain During Carotid Endarterectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Debrecen'}, 'officialTitle': 'Investigation of Blood Flow Velocity in the MCA and Oxygen Saturation of the Brain During Carotid Endarterectomy in Local Anesthesia in Patients With and Without Neurological Symptoms Using Transcranial Doppler (TCD) and INVOS Monitor', 'orgStudyIdInfo': {'id': 'DE RKEB/IKEB:4364/2015'}, 'secondaryIdInfos': [{'id': '094579/2015/OTIG', 'type': 'OTHER', 'domain': 'Health Registration and Training Center Department of Medical Devices'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients without neurological symptoms', 'description': "carotid endarterectomy patients who dont'have any neurological symptoms after carotid clamping", 'interventionNames': ['Device: transcranial Doppler (TCD) and INVOS monitor']}, {'label': 'patients with neurological symptoms', 'description': 'carotid endarterectomy patients who have new neurological symptoms after carotid clamping', 'interventionNames': ['Device: transcranial Doppler (TCD) and INVOS monitor']}], 'interventions': [{'name': 'transcranial Doppler (TCD) and INVOS monitor', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['patients with neurological symptoms', 'patients without neurological symptoms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4032', 'city': 'Debrecen', 'state': 'Hajdú-Bihar', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Béla Fülesdi, MD PhD DSci', 'role': 'CONTACT', 'phone': '00 36 52 255 347'}, {'name': 'Zoltán Gyöngyösi, md', 'role': 'CONTACT', 'phone': '00 36 52 255 347'}], 'facility': 'University of Debrecen', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '4032', 'city': 'Debrecen', 'status': 'ENROLLING_BY_INVITATION', 'country': 'Hungary', 'facility': 'University of Debrecen', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}], 'centralContacts': [{'name': 'Zoltán Mr Gyöngyösi, Md', 'role': 'CONTACT', 'email': 'zozman77@gmail.com', 'phone': '+3630/2883970'}, {'name': 'Erzsébet Igbonu-nagy, nurse', 'role': 'CONTACT', 'email': 'nagyboske@yahoo.com', 'phone': '+3620/3991551'}], 'overallOfficials': [{'name': 'Béla Fülesdi, MD,PhD,DSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hungary University of Debrecen Debrecen, Hungary, 4032'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Debrecen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor anesthesiologist and intensive care specialist', 'investigatorFullName': 'Tamas Vegh, MD', 'investigatorAffiliation': 'University of Debrecen'}}}}