Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
Study NCT ID:
NCT03841968
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2019-02-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dynamic SAX vs Conventional LAX in Internal Jugular Vein Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-26', 'studyFirstSubmitDate': '2019-02-11', 'studyFirstSubmitQcDate': '2019-02-13', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First pass success rate of the internal jugular vein catheterization_confirmation of the central venous pressure through a patient monitor', 'timeFrame': 'Intraoperative', 'description': 'First pass success rate of the internal jugular vein catheterization\\_confirmation of the central venous pressure through a patient monitor'}], 'secondaryOutcomes': [{'measure': 'Total procedure time', 'timeFrame': 'Intraoperative', 'description': 'Total procedure time'}, {'measure': 'Rate of posterior wall puncture_assessed by ultrasound', 'timeFrame': 'Intraoperative', 'description': 'Rate of posterior wall puncture\\_assessed by ultrasound'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Surgical Procedures', 'Central Venous Catheterization', 'Ultrasonography']}, 'descriptionModule': {'briefSummary': 'Conventionally, short-axis out-of-plane (SAX) or long-axis in-plane (LAX) ultrasound views are commonly used to guide internal jugular vein catheterization.\n\nSAX dynamic needle tip positioning (SAX-DNTP) is a novel ultrasound imaging technique that enables continuous visualization of the needle tip during ultrasound-guided cannulation; When the needle tip is imaged as a hyperechoic dot, the ultrasound probe is moved a few millimeters, and then the needle is advanced until the needle tip reappears in the vessel lumen. The process is repeated until the needle is advanced more than 1 cm into the lumen. The catheter is then introduced into the vessel.\n\nThe aim of this study was to compare the first pass success rate of internal jugular vein catheterization between SAX-DNTP and the conventional LAX technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective cardiac surgery where central venous catheterization is required.\n\nExclusion Criteria:\n\n* skin infection or trauma\n* Shock\n* Patients on ECMO or IABP support\n* Morbid obesity\n* Profound coagulopathy'}, 'identificationModule': {'nctId': 'NCT03841968', 'briefTitle': 'Dynamic SAX vs Conventional LAX in Internal Jugular Vein Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Randomized Trial of Ultrasound-guided Right Internal Jugular Vein Catheterization Using Dynamic Short Axis Versus Conventional Long-axis View in Cardiac Surgery Patients: a Dual-center Randomized Trial', 'orgStudyIdInfo': {'id': 'DNTP IJV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dynamic needle tip positioning', 'description': 'Dynamic needle tip positioning', 'interventionNames': ['Procedure: Dynamic needle tip positioning under ultrasound-guidance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional long-axis', 'description': 'Conventional long-axis', 'interventionNames': ['Procedure: Conventional long-axis view']}], 'interventions': [{'name': 'Dynamic needle tip positioning under ultrasound-guidance', 'type': 'PROCEDURE', 'description': 'The tip of needle is positioned under ultrasound-guidance using dynamic short-axis view.', 'armGroupLabels': ['Dynamic needle tip positioning']}, {'name': 'Conventional long-axis view', 'type': 'PROCEDURE', 'description': 'The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.', 'armGroupLabels': ['Conventional long-axis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': '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'}, 'collaborators': [{'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}