Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 10:17 AM
Study NCT ID:
NCT01352260
Status:
COMPLETED
Last Update Posted:
2012-05-21
First Post:
2011-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Near-Infrared Spectroscopy Comparison Study
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': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-18', 'studyFirstSubmitDate': '2011-05-10', 'studyFirstSubmitQcDate': '2011-05-10', 'lastUpdatePostDateStruct': {'date': '2012-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Linear correlation between absolute value of cerebral oxygen saturation (rSO2) compared to Jugular Venous Oxygen Saturation (SjvO2). Sensitivity and specificity to detect < 60% desaturation.', 'timeFrame': 'At the end of the surgical case approximately 6 to 8 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Near Infrared Spectroscopy', 'Neuromonitoring', 'Aortic Arch Replacement'], 'conditions': ['Total Aortic Arch Replacement']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System, Somanetics; Troy, MI) with four-wavelength NIRS (Nonin Medical, Inc; Plymouth, MN) to determine which modality best correlates with jugular venous oxygen saturation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Baylor College of Medicine and affiliated Hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provide written informed consent from patient or legally authorized representative before surgery\n2. Adult patients 18-65 years of age\n3. Presenting for elective or urgent total aortic arch repair under moderate hypothermic circulatory arrest (Nasopharyngeal temperature 20 - 24 ºC) with selective antegrade cerebral perfusion -\n\nExclusion Criteria:\n\n1. Patients will be excluded from this study if they are age less than 18\n2. Are undergoing an emergent procedure\n3. Have a history of insulin-dependent diabetes mellitus\n4. Have a history of stroke\n5. Are undergoing a redo sternotomy during which major bleeding occurs necessitating transfusion of \\> 4 units of packed red blood cells prior to the institution of circulatory arrest\n6. Patients in whom a left jugular venous bulb cannula cannot successfully be placed'}, 'identificationModule': {'nctId': 'NCT01352260', 'briefTitle': 'Near-Infrared Spectroscopy Comparison Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nonin Medical, Inc'}, 'officialTitle': 'Validation of Near-Infrared Spectroscopy for Neuromonitoring During Moderate Hypothermic Circulatory Arrest for Total Aortic Arch Replacement: A Comparison of Two Technologies With Jugular Venous Bulb Oximetry', 'orgStudyIdInfo': {'id': 'H-27855'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac Disease', 'description': 'Total Aortic Arch Replacement'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine and affiliated Hospitals', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Wei Pan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nonin Medical, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Baylor College of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}