Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-02-17 @ 11:37 PM
Study NCT ID:
NCT02630550
Status:
UNKNOWN
Last Update Posted:
2015-12-15
First Post:
2015-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Cheetah NICOM by Comparison to TEE During Open Vascular Surgery - Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017548', 'term': 'Echocardiography, Transesophageal'}], 'ancestors': [{'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2015-12-10', 'lastUpdatePostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity of Stroke Volume (SV) Measurements by the Cheetah NICOM', 'timeFrame': 'Per vascular surgery procedure', 'description': 'The SV measured by the Cheetah NICOM will be compared to the one measured by transesophageal echocardiography at multiple time points during the surgery.'}], 'secondaryOutcomes': [{'measure': 'Stroke Volume (SV) with a vascular cross-clamp', 'timeFrame': 'Per vascular surgery procedure when a cross-clamp is installed', 'description': 'The SV measured by the Cheetah NICOM will be compared to the one measured by transesophageal echocardiography at multiple points once a vascular cross-clamp is installed.'}, {'measure': 'Stroke Volume (SV) trending ability', 'timeFrame': 'Per vascular surgery procedure', 'description': 'Between each pair of consecutive data points, the change of SV measurements given by the Cheetah NICOM will be compared to those given by transesophageal echocardiography.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac output', 'Intraoperative Monitoring', 'Echocardiography, Transesophageal', 'Vascular cross-clamping', 'Endarterectomy', 'Monitoring, Physiologic/instrumentation', 'Cardiography, Impedance'], 'conditions': ['Aortic Aneurysm', 'Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': "The Cheetah NICOM is a non-invasive cardiac output monitor that has been validated in various clinical contexts but not during the occlusion of major arteries, as takes place in vascular surgery. The present study will evaluate the precision and validity of the measures taken by the device during open vascular surgery procedures. The measurements will be compared to the those calculated by transesophageal echocardiography at various key points during the surgeries. The validity of the cardiac output, stroke volume and stroke volume variation measurements will be evaluated, as well as the device's ability to track rapid changes in cardiac output."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing either an open aortic aneurysm repair surgery or a femoral endarterectomy under general anesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing an elective open aortic aneurysm repair surgery or a femoral endarterectomy under general anesthesia.\n* ASA 1-3\n\nExclusion Criteria:\n\n* Refuses general anesthesia\n* Contraindication to transesophageal echocardiography\n* Allergy to the glue of the Cheetah NICOM probes\n* Severe aortic valve regurgitation\n* Thoracic aorta anatomy anomaly\n* Unipolar pacemaker'}, 'identificationModule': {'nctId': 'NCT02630550', 'briefTitle': 'Validation of the Cheetah NICOM by Comparison to TEE During Open Vascular Surgery - Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Maisonneuve-Rosemont Hospital'}, 'officialTitle': 'Validation of the Cheetah NICOM by Comparison to TEE During Open Vascular Surgery - Pilot Study', 'orgStudyIdInfo': {'id': '15042'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aortic Aneurysm Repair', 'description': "The impact of large abdominal retractors and an abdominal aortic cross-clamp on the validity of the Cheetah NICOM's measurements will be evaluated in this group.", 'interventionNames': ['Device: Cheetah NICOM', 'Device: Transesophageal echocardiography (TEE)']}, {'label': 'Femoral Endarterectomy', 'description': "The impact of the clamping of a large peripheral arterial vessel on the validity of the Cheetah NICOM's measurements will be evaluated in this group.", 'interventionNames': ['Device: Cheetah NICOM', 'Device: Transesophageal echocardiography (TEE)']}], 'interventions': [{'name': 'Cheetah NICOM', 'type': 'DEVICE', 'description': 'The Cheetah NICOM will be installed on all patients to evaluate the validity of its measurements.', 'armGroupLabels': ['Aortic Aneurysm Repair', 'Femoral Endarterectomy']}, {'name': 'Transesophageal echocardiography (TEE)', 'type': 'DEVICE', 'description': 'TEE will serve as gold standard measurements for the evaluation of the Cheetah NICOM.', 'armGroupLabels': ['Aortic Aneurysm Repair', 'Femoral Endarterectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nadia Godin, RN', 'role': 'CONTACT', 'email': 'ngodin.hmr@ssss.gouv.qc.ca', 'phone': '252-3400', 'phoneExt': '3193'}, {'name': 'Louis-Philippe Fortier, MSc,MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maisonneuve-Rosemont Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Eric Peters', 'role': 'CONTACT', 'phone': '514-252-3400'}, {'name': 'Nadia Godin, RN', 'role': 'CONTACT', 'phone': '514-252-3400', 'phoneExt': '3193'}], 'overallOfficials': [{'name': 'Louis-Philippe Fortier, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maisonneuve-Rosemont Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maisonneuve-Rosemont Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department Head - Anesthesia', 'investigatorFullName': 'Louis-Philippe Fortier', 'investigatorAffiliation': 'Maisonneuve-Rosemont Hospital'}}}}