Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-01-26 @ 7:23 PM
Study NCT ID:
NCT03784118
Status:
COMPLETED
Last Update Posted:
2024-10-17
First Post:
2018-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complications Associated with Arterial Line Placement in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D000081282', 'term': 'Perfusion Index'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2018-12-11', 'studyFirstSubmitQcDate': '2018-12-19', 'lastUpdatePostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of complications associated with arterial catheterization', 'timeFrame': 'within 5 days after arterial catheterization', 'description': 'Number of participants with complications following arterial catheterization. The complications include thrombus, ischemia, oozing or bleeding, and color change, etc. If any of these occur, it is assumed that complications have occurred.'}], 'secondaryOutcomes': [{'measure': 'Time-dependent changes in perfusion index', 'timeFrame': 'from arterial catheterization to the end of surgery', 'description': 'Perfusion index was continuously monitored throughout surgery, on both sides: the digit on the side of the arterial line placement and the opposite side'}, {'measure': 'Age as a risk factor', 'timeFrame': 'within 5 days after arterial catheterization', 'description': 'To evaluate the age as one of the risk factors for complications following arterial catheterization using univariable logistic regression analysis.'}, {'measure': 'Number of attempts as a risk factor', 'timeFrame': 'within 5 days after arterial catheterization', 'description': 'To evaluate the number of attempts of arterial catheterization as one of the risk factors for complications'}, {'measure': 'Duration of catheterization as a risk factor', 'timeFrame': 'within 5 days after arterial catheterization', 'description': 'To evaluate the duration of catheterization as one of the risk factors for complications'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complications After Arterial Catheterization']}, 'referencesModule': {'references': [{'pmid': '40923190', 'type': 'DERIVED', 'citation': 'Lee JH, Park JB, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS. Immediate complications and risk factors following radial arterial catheterisation in paediatric patients at a tertiary centre. Eur J Anaesthesiol. 2025 Sep 8. doi: 10.1097/EJA.0000000000002268. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find the risk factors for complications following arterial line catheterization. Ultrasonography is used to evaluate the size of artery which is cannulated, before and after catheterization. The complications include ischemia, bleeding, thrombosis and so on.', 'detailedDescription': 'artery observation with ultrasound'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients under 5 years of age who require invasive arterial pressure monitoring\n\nExclusion Criteria:\n\n* Patients who do not need invasive arterial pressure monitoring'}, 'identificationModule': {'nctId': 'NCT03784118', 'briefTitle': 'Complications Associated with Arterial Line Placement in Children', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Study on Complications After Arterial Line Placement and the Risk Factors in Children', 'orgStudyIdInfo': {'id': 'H1812-032-991'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Children', 'description': 'Children who are followed up after arterial catheterization for evaluation of complications, using ultrasonography', 'interventionNames': ['Diagnostic Test: Ultrasonography', 'Diagnostic Test: perfusion index']}], 'interventions': [{'name': 'Ultrasonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasonography is used to evaluate the change in artery size after arterial catheterization and to assess the complication in children', 'armGroupLabels': ['Children']}, {'name': 'perfusion index', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurement of perfusion index immediately after arterial catheterization until surgery end, in arterial catheterization site and contralateral site.', 'armGroupLabels': ['Children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hee-Soo Kim Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hee-Soo Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}