Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT02230358
Status:
COMPLETED
Last Update Posted:
2021-09-13
First Post:
2014-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Output and Duplex Sonography in Carotid Endarterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D017585', 'term': 'Ultrasonography, Doppler, Transcranial'}, {'id': 'D001784', 'term': 'Blood Gas Analysis'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'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'}, {'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-06', 'studyFirstSubmitDate': '2014-07-31', 'studyFirstSubmitQcDate': '2014-08-29', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Influence of anesthetic technique on near infrared spectroscopy during carotid endarterectomy.', 'timeFrame': 'Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit', 'description': 'Number of participants: 90 patients\n\nUnit of measure: blood flow, volume and absolute tissue saturation\n\nNear infrared spectroscopy will be measured and compared at the following time points:\n\n* T0 Baseline (after insertion of an arterial line)\n* T1 After induction of anesthesia, but before surgical start\n* T2 Two minutes after clamping the carotid artery\n* T3 Two minutes after shunt insertation of the carotid artery\n* T4 After reperfusion\n* T5 After completion of the skin suture'}, {'measure': 'Influence of anesthetic technique on blood pressure during carotid endarterectomy.', 'timeFrame': 'Change of blood pressure, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit', 'description': 'Number of participants: 90 patients\n\nUnit of measure: blood pressure in mmHg\n\nBlood pressure will be measured and compared at the following time points:\n\n* T0 Baseline (after insertion of an arterial line)\n* T1 After induction of anesthesia, but before surgical start\n* T2 Two minutes after clamping the carotid artery\n* T3 Two minutes after shunt insertation of the carotid artery\n* T4 After reperfusion\n* T5 After completion of the skin suture'}, {'measure': 'Percentage of participants with death.', 'timeFrame': 'Up to 6 months'}, {'measure': 'Number of participants with transient ischemic attack and neck hematoma requiring surgical revision.', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 5 weeks'}, {'measure': 'Percentage of participants with myocardial infarction.', 'timeFrame': 'Up to 6 months'}, {'measure': 'Percentage of participants with stroke.', 'timeFrame': 'Up to 6 months'}, {'measure': 'Influence of anesthetic technique on heart rate during carotid endarterectomy', 'timeFrame': 'Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit', 'description': 'Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit\n\nNumber of participants: 90 patients\n\nUnit of measure: beats per minute (bpm)\n\nHeart rate will be measured and compared at the following time points:\n\n* T0 Baseline (after insertion of an arterial line)\n* T1 After induction of anesthesia, but before surgical start\n* T2 Two minutes after clamping the carotid artery\n* T3 Two minutes after shunt insertation of the carotid artery\n* T4 After reperfusion\n* T5 After completion of the skin suture'}, {'measure': 'Influence of anesthetic technique on blood gas analysis during carotid endarterectomy', 'timeFrame': 'Change of oxygen saturation in blood, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit', 'description': 'Number of participants: 90 patients\n\nUnit of measure: arterial oxygen tension (PaO2)\n\nBlood pressure will be measured and compared at the following time points:\n\n* T0 Baseline (after insertion of an arterial line)\n* T1 After induction of anesthesia, but before surgical start\n* T2 Two minutes after clamping the carotid artery\n* T3 Two minutes after shunt insertation of the carotid artery\n* T4 After reperfusion\n* T5 After completion of the skin suture'}], 'primaryOutcomes': [{'measure': 'Influence of anesthetic technique on cardiac output during carotid endarterectomy.', 'timeFrame': 'Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit', 'description': 'Number of participants: 90 patients\n\nUnit of measure: Cardiac index (l/m2)\n\nCardiac output will be measured and compared at the following time points:\n\n* T0 Baseline (after insertion of an arterial line)\n* T1 After induction of anesthesia, but before surgical start\n* T2 Two minutes after clamping the carotid artery\n* T3 Two minutes after shunt insertation of the carotid artery\n* T4 After reperfusion\n* T5 After completion of the skin suture'}], 'secondaryOutcomes': [{'measure': 'Influence of anesthetic technique on trans-cranial doppler flow during carotid endarterectomy.', 'timeFrame': 'Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit', 'description': 'Cerebral blood flow will be measured via trans-cranial Doppler (TCD) and compared at the following time points:\n\n* T0 Baseline (after insertion of an arterial line)\n* T1 After induction of anesthesia, but before surgical start\n* T2 Two minutes after clamping the carotid artery\n* T3 Two minutes after shunt insertation of the carotid artery\n* T4 After reperfusion\n* T5 After completion of the skin suture'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['carotid endarterectomy', 'cardiac output', 'trans-cranial Doppler', 'CEA', 'regional anesthesia', 'general anesthesia'], 'conditions': ['Carotid Stenosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the differences between the cardiac output and the cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a randomized, controlled, single center study at the Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine.', 'detailedDescription': 'The investigators will investigate the differences between the cardiac output and the cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a randomized, controlled, single center study at the Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine.\n\nFor this purpose patients with the need of a carotid endarterectomy (CEA) will be included and randomized either to the regional anesthesia (RA) or the general anesthesia (GA) group until a patient number of 45 in each group is achieved.\n\nThe cardiac output and cerebral blood-flow via trans-cranial Doppler (TCD) will be measured at 6 time points:\n\n* T0 Baseline (after insertion of an arterial line)\n* T1 After induction of anesthesia, but before surgical start\n* T2 Two minutes after clamping the carotid artery\n* T3 Two minutes after shunt insertation of the carotid artery\n* T4 After reperfusion\n* T5 After completion of the skin suture'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>= 18 years\n2. Elective carotid endarterectomy\n3. Signed informed consent\n\nExclusion Criteria:\n\n1. Age under 18 years\n2. Missing signed informed consent'}, 'identificationModule': {'nctId': 'NCT02230358', 'briefTitle': 'Cardiac Output and Duplex Sonography in Carotid Endarterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Cardiac Output and Cerebral Blood-flow During Carotid Endarterectomy in Regional vs. General Anesthesia. A Prospective Randomized Controlled Single Center Study', 'orgStudyIdInfo': {'id': 'CODUCE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Regional anesthesia (RA)', 'description': "Regional anesthesia (RA) for a carotid endarterectomy Interventions: Regional anesthesia (RA), blood gas analysis, 'Transcranieller Doppler' (Transcranial Doppler ultrasonography), invasive arterial blood pressure measurement, arterial blood gas measurement, neurological control, Near-infrared spectroscopy (NIRS) monitoring, oxygen supply (not invasive 'Vigileo')", 'interventionNames': ['Procedure: Regional anesthesia', 'Device: Transcranial Doppler ultrasonography', 'Procedure: blood gas analysis', 'Procedure: invasive arterial blood pressure measurement', 'Procedure: arterial blood gas measurement', 'Behavioral: Neurological Control', 'Behavioral: NIRS monitoring', "Device: oxygen supply (not invasive 'Vigileo')"]}, {'type': 'OTHER', 'label': 'General anesthesia (GA)', 'description': "General anesthesia (GA) for a carotid endarterectomy Interventions: General anesthesia, blood gas analysis, 'Transcranieller Doppler' (Transcranial Doppler ultrasonography), invasive arterial blood pressure measurement, arterial blood gas measurement, neurological control, NIRS monitoring, oxygen supply (not invasive 'Vigileo')", 'interventionNames': ['Procedure: General anesthesia', 'Device: Transcranial Doppler ultrasonography', 'Procedure: blood gas analysis', 'Procedure: invasive arterial blood pressure measurement', 'Procedure: arterial blood gas measurement', 'Behavioral: Neurological Control', 'Behavioral: NIRS monitoring', "Device: oxygen supply (not invasive 'Vigileo')"]}], 'interventions': [{'name': 'Regional anesthesia', 'type': 'PROCEDURE', 'description': 'Regional anesthesia', 'armGroupLabels': ['Regional anesthesia (RA)']}, {'name': 'General anesthesia', 'type': 'PROCEDURE', 'description': 'General anesthesia', 'armGroupLabels': ['General anesthesia (GA)']}, {'name': 'Transcranial Doppler ultrasonography', 'type': 'DEVICE', 'description': '6x for 4 hours', 'armGroupLabels': ['General anesthesia (GA)', 'Regional anesthesia (RA)']}, {'name': 'blood gas analysis', 'type': 'PROCEDURE', 'description': '6 x 3 ml blood withdrawal (18 ml) within 4 hours', 'armGroupLabels': ['General anesthesia (GA)', 'Regional anesthesia (RA)']}, {'name': 'invasive arterial blood pressure measurement', 'type': 'PROCEDURE', 'description': 'before operation, 8 hours, as done in clinical routine', 'armGroupLabels': ['General anesthesia (GA)', 'Regional anesthesia (RA)']}, {'name': 'arterial blood gas measurement', 'type': 'PROCEDURE', 'description': 'perioperative, 4-6 times within 8 hours, as done in clinical routine', 'armGroupLabels': ['General anesthesia (GA)', 'Regional anesthesia (RA)']}, {'name': 'Neurological Control', 'type': 'BEHAVIORAL', 'description': 'perioperative, 2-3 days, as done in clinical routine', 'armGroupLabels': ['General anesthesia (GA)', 'Regional anesthesia (RA)']}, {'name': 'NIRS monitoring', 'type': 'BEHAVIORAL', 'description': 'perioperative, for 5 hours, as done in clinical routine', 'armGroupLabels': ['General anesthesia (GA)', 'Regional anesthesia (RA)']}, {'name': "oxygen supply (not invasive 'Vigileo')", 'type': 'DEVICE', 'description': 'perioperative for 5 hours, as done in clinical routine', 'armGroupLabels': ['General anesthesia (GA)', 'Regional anesthesia (RA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Medical University Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'overallOfficials': [{'name': 'Corinna Velik-Salchner, PrivDoz.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Innsbruck'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Priv.-Doz. Dr.', 'investigatorFullName': 'Priv.Doz. Dr. Corinna Velik-Salchner', 'investigatorAffiliation': 'Medical University Innsbruck'}}}}