Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-03-20 @ 8:55 PM
Study NCT ID:
NCT01003366
Status:
COMPLETED
Last Update Posted:
2011-03-22
First Post:
2009-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Bevel Direction of Puncture Needle on Success Rate and Complications During Central Venous Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 338}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-18', 'studyFirstSubmitDate': '2009-10-27', 'studyFirstSubmitQcDate': '2009-10-27', 'lastUpdatePostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'posterior wall puncture of internal jugular vein', 'timeFrame': 'immediately after catheterization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['safety during central venous catheterization'], 'conditions': ['Central Venous Catheterization']}, 'descriptionModule': {'briefSummary': 'To test the hypothesis that approaching the internal jugular vein with the needle bevel down would produce less injury to the vessel wall compared to the bevel up approach during central venous catheterization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing surgery that requires the placement of a central venous catheter at the internal jugular vein\n\nExclusion Criteria:\n\n* anatomical anomaly in the neck region\n* recent history of central venous catheterization'}, 'identificationModule': {'nctId': 'NCT01003366', 'briefTitle': 'Effect of the Bevel Direction of Puncture Needle on Success Rate and Complications During Central Venous Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'JHBahk_CVC bevel'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bevel down', 'description': 'approaching the IJV with the needle bevel facing down', 'interventionNames': ['Device: bevel direction during central venous catheterization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bevel up', 'description': 'approaching the IJV with the needle bevel facing up', 'interventionNames': ['Device: bevel direction during central venous catheterization']}], 'interventions': [{'name': 'bevel direction during central venous catheterization', 'type': 'DEVICE', 'description': 'approaching the IJV with the needle bevel facing down', 'armGroupLabels': ['bevel down']}, {'name': 'bevel direction during central venous catheterization', 'type': 'DEVICE', 'description': 'approaching the IJV with the needle bevel facing up', 'armGroupLabels': ['bevel up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jae-Hyon Bahk', 'oldOrganization': 'Seoul National University Hospital'}}}}