Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT03530618
Status:
COMPLETED
Last Update Posted:
2021-09-20
First Post:
2018-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Central Line Catheterization With Flexible Tip Straight Guidewire in Small Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2018-05-08', 'lastUpdatePostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First successful central venous catheterization rate', 'timeFrame': 'Interval between skin penetration of the needle 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 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 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 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 after guide wire insertion, an expected average of 90 seconds'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Catheterization, Central Venous']}, 'referencesModule': {'references': [{'pmid': '35793466', 'type': 'DERIVED', 'citation': 'Kim EH, Kang P, Song IS, Ji SH, Jang YE, Lee JH, Kim HS, Kim JT. Straight-tip guidewire versus J-tip guidewire for central venous catheterisation in neonates and small infants: A randomised controlled trial. Eur J Anaesthesiol. 2022 Aug 1;39(8):656-661. doi: 10.1097/EJA.0000000000001695. Epub 2022 Jul 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 flexible tip straight guidewire and J-tip guidewire for ultrasound-guided central venous catheterization in small children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', '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': 'NCT03530618', 'briefTitle': 'Central Line Catheterization With Flexible Tip Straight Guidewire in Small Children', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Central Line Insertion Technique in Small Infants Using Flexible Tip Straight Guidewire and J-tip Guidewire: a Randomized Controlled Trials', 'orgStudyIdInfo': {'id': 'H-1803-150-935'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flexible tip straight guidewire', 'interventionNames': ['Device: Flexible tip straight guidewire']}, {'type': 'EXPERIMENTAL', 'label': 'J-tip guidewire', 'interventionNames': ['Device: J-tip']}], 'interventions': [{'name': 'Flexible tip straight guidewire', 'type': 'DEVICE', 'description': 'Use a flexible tip straight guidewire for ultrasound-guided central venous catheterization', 'armGroupLabels': ['Flexible tip straight guidewire']}, {'name': 'J-tip', 'type': 'DEVICE', 'description': 'Use a J tip straight guidewire for ultrasound-guided central venous catheterization', 'armGroupLabels': ['J-tip guidewire']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Tae Kim, Professor', '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': 'professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}