Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-02-19 @ 12:36 PM
Study NCT ID:
NCT02492932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-01
First Post:
2015-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Second Try During Landmark Approach of the Internal Jugular Vein: an Ultrasonographic Prelocation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 323}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2015-06-09', 'studyFirstSubmitQcDate': '2015-07-08', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of internal jugular vein cannulation at the second attempt after failure of first attempt on ultrasonographic simulation', 'timeFrame': 'intraoperative'}], 'secondaryOutcomes': [{'measure': 'Degree of lateral rotation or medial movement for successful puncture of second attemp', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Jugular Veins']}, 'descriptionModule': {'briefSummary': 'Two approaches are possible when the first finder needle attempt of the internal jugular vein cannulation fails; the needle can be turned slightly laterally or the puncture point can be moved slightly medially. This study is an ultrasonographic stimulation study to evaluate the success rate of turning the needle laterally and moving the puncture point medially, and to determine the proper angle or distance for the second try of internal jugular vein cannulation.', 'detailedDescription': 'Immediately after induction of general anesthesia, the patient\'s head is turned slightly, and the table is tilted at 10 degrees, and the puncture point estimated by the anatomical landmarks are marked on the patient\'s skin. The investigators obtain a sonographic view at the estimated puncture point. It is recorded "success" when the internal jugular vein is visualized on the ultrasonography, and the estimated needle path passes the internal jugular vein. It is recorded "failure" if the internal jugular vein is not visualized on the ultrasonography, and the estimated needle path does not pass the internal jugular vein. After "failure" of the first attempt, the probe is either turned laterally or moved medially until the internal jugular vein is visualized on the ultrasonography, and the estimated needle path passes the internal jugular vein. The angle and distance is recorded. The location of the carotid artery is always marked on the ultrasonography for evaluation of complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for general anesthesia\n\nExclusion Criteria:\n\n* Refusal of consent\n* Patients with C-spine injuries\n* Patients with atlanto-axial instability\n* Patients at risk of increased intracranial pressure'}, 'identificationModule': {'nctId': 'NCT02492932', 'briefTitle': 'The Second Try During Landmark Approach of the Internal Jugular Vein: an Ultrasonographic Prelocation Study', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Second Try During Landmark Approach of the Internal Jugular Vein: an Ultrasonographic Prelocation Study', 'orgStudyIdInfo': {'id': 'CWJung_IJV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IJV_2nd', 'description': 'Ultrasonography examination of the patients who are assumed to take second attempt of internal jugular venous catheterization', 'interventionNames': ['Device: Ultrasonography']}], 'interventions': [{'name': 'Ultrasonography', 'type': 'DEVICE', 'description': 'Ultrasonography evaluation of the internal jugular vein.', 'armGroupLabels': ['IJV_2nd']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Chul-Woo Jung', 'role': 'CONTACT', 'email': 'jungcwoo@gmail.com', 'phone': '82-2-2072-0640'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Chul-Woo Jung', 'role': 'CONTACT', 'email': 'jungcwoo@gmail.com', 'phone': '82-2-2072-2467'}], 'overallOfficials': [{'name': 'Chul-Woo Jung', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Chul-Woo Jung', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}