Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT06386718
Status:
RECRUITING
Last Update Posted:
2025-04-27
First Post:
2024-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasonographic Evaluation of Arteries of the Hand in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determining the Diameter and Depth at different angles', 'timeFrame': 'only once', 'description': 'The study aims to measure the radial and ulnar arteries using ultrasound at different angles to determine the widest diameter and the optimal angle to achieve this diameter.'}, {'measure': 'Comparing Ulnar and Radial Artery Diameters Across Age Groups', 'timeFrame': 'only once', 'description': 'Investigating whether there is a difference (ulnar\\>radial, ulnar=radial, or radial\\>ulnar) in the diameter of the ulnar artery compared to the radial artery among the age groups included in the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasonography for cannulation', 'pediatrics'], 'conditions': ['Ulnar and Radial Artery']}, 'descriptionModule': {'briefSummary': 'Ultrasound measurements of the ulnar artery and radial artery at different angles are obtained and compared to determine the optimal diameters for possible arterial cannulation in pediatric patients.', 'detailedDescription': 'Radial artery cannulation is the most commonly used technique for invasive arterial catheterization in pediatric patients. Ultrasound guidance has significantly reduced cannulation success rates and complication risks. The ulnar artery presents an anatomical alternative to the radial artery and has emerged as a potential cannulation site. This study aims to comprehensively evaluate the suitability of the radial or ulnar artery for cannulation in pediatric patients.\n\nFinding of this study objectives are\n\nTo obtain a large sample of pediatric patients from different age groups To measure arterial diameters using ultrasound at different angles and with ultrasound and to assess the optimal artery and the angle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Between 0 and 10 years of ages pediatric patients scheduled for elective surgery under general anesthesia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status 1 or 2\n* Patients scheduled for elective surgical procedures\n* Informed consent must be obtained from both the patient and, if applicable, their parent or guardian.\n\nExclusion Criteria:\n\n* Patients over 10 years of age\n* Patients with congenital anomalies or syndromic conditions\n* Abnormal Allen Test\n* Skin Erosion or infection at the cannulation site\n* Hematoma at the cannulation site'}, 'identificationModule': {'nctId': 'NCT06386718', 'briefTitle': 'Ultrasonographic Evaluation of Arteries of the Hand in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Comparison of Ultrasonographic Measurements of Radial and Ulnar Arteries in Pediatric Patients Undergoing Elective Surgery', 'orgStudyIdInfo': {'id': 'USG for ped art can'}}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Zeynep Altinbas, MD', 'role': 'CONTACT', 'email': 'szpostalcioglu@gmail.com', 'phone': '+905356082156'}, {'name': 'Ozlem S Can, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zeynep S Altinbas, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ankara University School Of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Ozlem S Can, MD', 'role': 'CONTACT', 'email': 'ozlemscan@gmail.com', 'phone': '+905323107914'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ozlem Can', 'investigatorAffiliation': 'Ankara University'}}}}