Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-04 @ 8:46 AM
Study NCT ID:
NCT02426268
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2015-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FORE-SIGHT Tissue Oximeter During Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2015-04-21', 'studyFirstSubmitQcDate': '2015-04-21', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral Oxygen Saturation', 'timeFrame': 'Duration of the surgery (~5-7 hours)', 'description': 'Two sensors from FORE-SIGHT Elite monitor will be placed on the forehead above the eyebrows to continuously monitor cerebral oxygen saturation.'}], 'secondaryOutcomes': [{'measure': 'Non-Cerebral Oxygen Saturation', 'timeFrame': 'Duration of the surgery (~5-7 hours)', 'description': 'Two sensors from FORE-SIGHT Elite monitor will be placed on the leg muscles to continuously monitor non-cerebral/skeletal muscle oxygen saturation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiac surgery', 'cerebral oximetry', 'lower extremity oximetry'], 'conditions': ['Cardiac Surgical Patients']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure cerebral and lower extremity oximetry on patients during cardiac surgery.', 'detailedDescription': 'The purpose of this research study is to collect data from a tissue oximeter device that measures brain oxygen saturation simultaneous with data from the same device that monitors skeletal muscle during cardiac surgery. This monitoring will allow for continuous, non-invasive, and earlier assessment of perfusion abnormalities/hypoperfusion.\n\nTwo sensors from the FORE-SIGHT Elite monitor will be placed on the forehead above the eyebrows and two additional sensors will be placed on the leg muscles. Data from the FORE-SIGHT Elite monitor will be recorded in addition to clinical and demographic data, which is standard of care during the procedure, for research purposes to look at factors associated with desaturations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cardiothoracic surgical population at UCLA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects where cerebral oximetry is monitored during their surgery\n\nExclusion Criteria:\n\n* Birthmarks, tattoos, or other skin abnormalities that FORE-SIGHT Sensors cannot avoid'}, 'identificationModule': {'nctId': 'NCT02426268', 'acronym': 'FORE-SIGHT', 'briefTitle': 'FORE-SIGHT Tissue Oximeter During Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'CAS Medical Systems FORE-SIGHT Elite Tissue Oximeter During Cardiac Surgery', 'orgStudyIdInfo': {'id': 'FORE-SIGHT 13-000448'}}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center, Department of Anesthesiology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Emily Methangkool, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'CAS Medical Systems, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Clinical Professor', 'investigatorFullName': 'Emily Methangkool, MD, MPH', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}