Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-02-11 @ 6:36 AM
Study NCT ID:
NCT02688595
Status:
COMPLETED
Last Update Posted:
2018-01-09
First Post:
2016-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Central Venous Catheterization Techniques in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-07', 'studyFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2016-02-17', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First successful central venous catheterization rate', 'timeFrame': 'Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes'}], 'secondaryOutcomes': [{'measure': 'Time to first puncture of central vein', 'timeFrame': 'Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds'}, {'measure': 'Time to guide wire insertion', 'timeFrame': 'Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds'}, {'measure': 'Total time to central venous catheterization', 'timeFrame': 'Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes'}, {'measure': 'Number of central vein puncture trial', 'timeFrame': 'up to 5 times, an expected average observation time of 30 seconds'}, {'measure': 'Number of guide wire insertion trial', 'timeFrame': 'up to 5 times, an expected average observation time of 90 seconds'}, {'measure': 'First successful central vein puncture rate', 'timeFrame': 'Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds'}, {'measure': 'First successful guide wire insertion rate', 'timeFrame': 'Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infant, Newborn', 'Ultrasonography'], 'conditions': ['Catheterization, Central Venous']}, 'referencesModule': {'references': [{'pmid': '15121722', 'type': 'BACKGROUND', 'citation': 'Grebenik CR, Boyce A, Sinclair ME, Evans RD, Mason DG, Martin B. NICE guidelines for central venous catheterization in children. Is the evidence base sufficient? Br J Anaesth. 2004 Jun;92(6):827-30. doi: 10.1093/bja/aeh134. Epub 2004 Apr 30.'}, {'pmid': '26248059', 'type': 'BACKGROUND', 'citation': 'Song IK, Lee JH, Kang JE, Oh HW, Kim HS, Park HP, Kim JT. Comparison of central venous catheterization techniques in pediatric patients: needle vs angiocath. Paediatr Anaesth. 2015 Nov;25(11):1120-6. doi: 10.1111/pan.12726. Epub 2015 Aug 6.'}, {'pmid': '30442261', 'type': 'DERIVED', 'citation': 'Song IK, Kim EH, Lee JH, Jang YE, Kim HS, Kim JT. Seldinger vs modified Seldinger techniques for ultrasound-guided central venous catheterisation in neonates: a randomised controlled trial. Br J Anaesth. 2018 Dec;121(6):1332-1337. doi: 10.1016/j.bja.2018.08.008. Epub 2018 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the Seldinger and modified Seldinger technique for ultrasound-guided central venous catheterization in neonates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgery under general anesthesia\n* require central venous catheterization\n\nExclusion Criteria:\n\n* central vein anomaly\n* hematoma in central vein\n* catheterization site infection'}, 'identificationModule': {'nctId': 'NCT02688595', 'briefTitle': 'Central Venous Catheterization Techniques in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Randomized Controlled Trial on Central Venous Catheterization Techniques in Neonates: Seldinger Versus Modified Seldinger', 'orgStudyIdInfo': {'id': '1601-108-736'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seldinger', 'description': 'Use a 23 gauge introducer needle for ultrasound-guided central venous catheterization', 'interventionNames': ['Device: Ultrasound', 'Other: General anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Modified Seldinger', 'description': 'Use a 22 gauge Angiocath Plus catheter for ultrasound-guided central venous catheterization', 'interventionNames': ['Device: Ultrasound', 'Other: General anesthesia']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'Ultrasound-guided central venous catheterization in internal jugular vein', 'armGroupLabels': ['Modified Seldinger', 'Seldinger']}, {'name': 'General anesthesia', 'type': 'OTHER', 'description': 'Scheduled operation under general anesthesia', 'armGroupLabels': ['Modified Seldinger', 'Seldinger']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Tae Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}