Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT04913493
Status:
TERMINATED
Last Update Posted:
2025-12-18
First Post:
2021-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital LOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}], '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'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'Not enough patient recruited', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2021-05-28', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of hospitalisation days. (LOS)', 'timeFrame': 'up to 30 Days', 'description': 'How long is the hospital Length-Of-Stay?'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carotid Artery Plaque', 'Aortic Aneurysm', 'Aneurysm']}, 'descriptionModule': {'briefSummary': 'the aim of this study is to determine whether an intraoperative optimization protocol using the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device in combination with intraoperative measurement of the sublingual microcirculation with the Cytocam-IDF device would result in an improvement in outcome in high-risk patients undergoing major vascular surgery, measured by the hospital LOS in comparison with intraoperative FloTrac/Vigileo monitoring alone.\n\nThe FloTrac/Vigileo device only needs standard arterial access for enhanced, flow-based hemodynamic monitoring. It is reported to be easy to use and easy to set up and calculates the stroke volume (SV) on the basis of the arterial waveform in combination with demographic data. Cardiac index (CI), stroke volume index (SVI) as an indicator for fluid status and stroke volume variation (SVV) as an indicator for fluid responsiveness during mechanical ventilation and sinus rhythm will be continuously measured during major vascular procedures, including carotid endarterectomy (CEA), open abdominal aortic aneurysm (AAA) repair , endovascular aneurysm repair (EVAR), thoracic endovascular aneurysm repair (TEVAR) and fenestrated endovascular aneurysm repair (FEVAR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Males and females\n* ASA III classification\n* Written informed consent obtained by the patient\n* Elective hospital admission for major vascular surgery procedures (CEA, open AAA, EVAR, TEVAR, FEVAR)\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Presence of permanent cardiac arrythmias\n* Weight \\< 55kg and \\> 140kg\n* Pregnancy\n* Emergency surgery\n* Minor vascular procedures\n* Refusal or inability to provide written informed consent (language barrier, mental retardation, dementia)'}, 'identificationModule': {'nctId': 'NCT04913493', 'briefTitle': 'Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital LOS', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital Length of Stay: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'FLOMIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients will only receive FloTrac/Vigileo monitoring which is standard of care.'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Patients will receive an additional medical imaging intervention. Namely sublingual microcirculation imaging with Cytocam-IDF.', 'interventionNames': ['Procedure: Cytocam-IDF']}], 'interventions': [{'name': 'Cytocam-IDF', 'type': 'PROCEDURE', 'description': 'Patients receive an extra medical imaging test perioperatively with the Cytocam-IDF', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}], 'overallOfficials': [{'name': 'Hélène De Cuyper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patients individual data will not be shared. Findings of the study will be published in a scientific article.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}