Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-05 @ 10:45 AM
Study NCT ID:
NCT03604094
Status:
COMPLETED
Last Update Posted:
2020-02-21
First Post:
2018-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Measurement of RIJV in Patients Between 0-2 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-20', 'studyFirstSubmitDate': '2018-07-19', 'studyFirstSubmitQcDate': '2018-07-19', 'lastUpdatePostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomical variations and dimensions of right internal jugular vein', 'timeFrame': '1 year', 'description': 'The central vein will be evaluated by ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['central venous catheter, pediatrics, ultrasound imaging'], 'conditions': ['Anatomic Abnormality', 'Internal Jugular Vein', 'Neonates', 'Infants, Premature', 'Children']}, 'descriptionModule': {'briefSummary': 'After obtaining parental consent ultrasonographic evaluation of right internal jugular vein will be performed in pediatric patients undergoing elective surgeries between 0-2 years of age. The patients for whom central venous catheterization is indicated will be included. The success rates and outcomes of catheterization will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy 0-2 year-old patients undergoing elective surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n0-2 years Elective surgery Requirement for central venous cannulation\n\nExclusion Criteria:\n\nCongenital cardiovascular anomalies Emergency surgeries Previous cannulation or any intervention on the neck'}, 'identificationModule': {'nctId': 'NCT03604094', 'briefTitle': 'Ultrasound Measurement of RIJV in Patients Between 0-2 Years', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Evaluation of Anatomical Variations and Dimensions of RIJV With Ultrasound in Pediatric Patients Between 0-2 Years', 'orgStudyIdInfo': {'id': 'Ultrasonography of RIJV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': '0-1 month old newborns', 'interventionNames': ['Procedure: Ultrasonographic evaluation']}, {'label': 'Group II', 'description': '1 month-2 year-old pediatric patients', 'interventionNames': ['Procedure: Ultrasonographic evaluation']}], 'interventions': [{'name': 'Ultrasonographic evaluation', 'type': 'PROCEDURE', 'description': 'Right internal jugular vein will be evaluated with ultrasound for anatomical variations and dimensions', 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Filiz Uzumcugil', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Asist. Prof.', 'investigatorFullName': 'Filiz Uzumcugil', 'investigatorAffiliation': 'Hacettepe University'}}}}