Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-01-07 @ 6:51 AM
Study NCT ID:
NCT02711761
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2016-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ideal Depth of Guide Wire for Central Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002405', 'term': 'Catheterization, Central Venous'}], 'ancestors': [{'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-08', 'studyFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2016-03-14', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of arrhythmia', 'timeFrame': 'during central venous catheterization'}]}, 'conditionsModule': {'conditions': ['Patient Safety During Central Venous Catheterization']}, 'descriptionModule': {'briefSummary': 'prospective randomized double-blind controlled study', 'detailedDescription': 'Total of 69 ASA (American Society of Anesthesiologist) physical status class I or II patients will be enrolled.\n\nRandomly assigned to three group according to the depth of guide-wire prior to tissue dilation during central catheterization via right internal jugular vein. (Group 1: 15 cm / Group 2: 17.5 cm / Group 3: 20 cm)\n\nCentral catheterization will be performed by anesthesiologists who be blinded to this study protocol.\n\nAn investigator will monitor and record whether any arrhythmia will occur.\n\nThe incidence of occurrence of arrhythmia will be compared between three groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients receiving general anesthesia requiring central venous catheterization via right internal jugular vein.\n* ASA (American Society of Anesthesiologist) physical status class I or II\n\nExclusion Criteria:\n\n* at the pre-anesthetic evaluation, history of any arrhythmia\n* when monitoring before the induction of anesthesia in the operating room, newly arrhythmia is observed.\n* abnormal electrolyte at the pre-anesthetic evaluation\n* too difficult to access right internal jugular vein for central catheterization (too short neck, infection at the site of right internal jugular vein, ventriculoperitoneal shunt or chemo-port existence at the site of right internal jugular vein. too close site to operating field)'}, 'identificationModule': {'nctId': 'NCT02711761', 'briefTitle': 'Ideal Depth of Guide Wire for Central Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Ideal Depth of Guide Wire for Right Internal Jugular Vein During Central Line Insertion', 'orgStudyIdInfo': {'id': '16-2015-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '15 cm', 'description': 'The depth of guide wire will be 15 cm from puncture site of skin prior to tissue dilation during central venous catheterization', 'interventionNames': ['Device: central venous catheterization']}, {'type': 'EXPERIMENTAL', 'label': '17.5 cm', 'description': 'The depth of guide wire will be 17.5 cm from puncture site of skin prior to tissue dilation during central venous catheterization', 'interventionNames': ['Device: central venous catheterization']}, {'type': 'ACTIVE_COMPARATOR', 'label': '20 cm', 'description': 'The depth of guide wire will be 20 cm from puncture site of skin prior to tissue dilation during central venous catheterization', 'interventionNames': ['Device: central venous catheterization']}], 'interventions': [{'name': 'central venous catheterization', 'type': 'DEVICE', 'description': '15 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 15 cm.\n\n17.5 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 17.5 cm.\n\n20 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 20 cm.', 'armGroupLabels': ['15 cm', '17.5 cm', '20 cm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Boramae Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jung-Man Lee, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Boramae Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Jung-Man Lee', 'investigatorAffiliation': 'Seoul National University Boramae Hospital'}}}}