Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-03 @ 8:18 PM
Study NCT ID:
NCT02795468
Status:
COMPLETED
Last Update Posted:
2018-04-26
First Post:
2016-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-24', 'studyFirstSubmitDate': '2016-05-26', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First-pass success rate', 'timeFrame': 'Within 10 min from the start time of arterial cannulation using an angiocath'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peripheral', 'Arterial', 'Catheterization'], 'conditions': ['Catheterization, Peripheral']}, 'referencesModule': {'references': [{'pmid': '33097369', 'type': 'DERIVED', 'citation': 'Huang HP, Zhao WJ, Wen F, Li XY. Application of ultrasound-guided radial artery cannulation in paediatric patients: A systematic review and meta-analysis. Aust Crit Care. 2021 Jul;34(4):388-394. doi: 10.1016/j.aucc.2020.09.001. Epub 2020 Oct 21.'}, {'pmid': '30431501', 'type': 'DERIVED', 'citation': 'Min JJ, Tay CK, Gil NS, Lee JH, Kim S, Kim CS, Yang JH, Jun TG. Ultrasound-guided vs. palpation-guided techniques for radial arterial catheterisation in infants: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):200-205. doi: 10.1097/EJA.0000000000000926.'}]}, 'descriptionModule': {'briefSummary': 'The investigators are trying to compare the ultrasound-guided technique vs. palpation method for radial arterial cannulation in infants.', 'detailedDescription': 'In infants (\\<12mo), radial arterial catheterization is sometimes difficult to perform. Moreover, repeated attempts itself would cause the arterial spasm or hematoma. The use of ultrasound as an adjunct to radial arterial cannulation has considered to be the best practice in adults and pediatrics. However, its usefulness or superiority for neonates and infants is not known. Therefore, we would compare ultrasound guided radial arterial cannulation with the usual palpation methods in infants undergoing cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants under 12 months age undergoing cardiac surgery with radial arterial cannulation\n\nExclusion Criteria:\n\n* Sign of a skin infection\n* Wound near the puncture site\n* abnormal circulation of the hand\n* any vascular problem at radial or ulnar artery'}, 'identificationModule': {'nctId': 'NCT02795468', 'briefTitle': 'The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants', 'orgStudyIdInfo': {'id': '2016-03-128-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Palpation group', 'description': 'The operator will use the pulsation of the radial artery as a guide for the cannulation.', 'interventionNames': ['Procedure: Radial arterial cannulation']}, {'type': 'EXPERIMENTAL', 'label': 'Ultrasound group', 'description': 'The ultrasound guided technique will be used to find a radial artery and insert a radial arterial catheter.', 'interventionNames': ['Procedure: Radial arterial cannulation']}], 'interventions': [{'name': 'Radial arterial cannulation', 'type': 'PROCEDURE', 'description': 'Radial arterial cannulation using usual palpation method or ultrasound guided technique according to the group', 'armGroupLabels': ['Palpation group', 'Ultrasound group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jong Hwan Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jong Hwan Lee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}