Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-15 @ 11:24 PM
Study NCT ID:
NCT06975566
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2025-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Effects of Radial Artery Cannulation on Vessel Diameter, Blood Flow and Fine Motor Skills
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2025-05-01', 'studyFirstSubmitQcDate': '2025-05-15', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '90 DAY FOLLOW-UP PERIOD', 'timeFrame': 'From the first measurement before cannulation to the last measurement after 90 days', 'description': 'Fifty patients requiring arterial cannulation were included in this study. Before the procedure, radial and ulnar artery Doppler parameters (peak systolic velocity, end-diastolic velocity, resistance index, pulsatility index, and mean volume flow) were measured for all patients, along with Purdue Pegboard scores for fine motor skill assessment. Post-cannulation Doppler parameters were assessed at seven different time points over three months, while fine motor skill scores were measured twice more.'}, {'measure': '90 DAY FOLLOW-UP PERIOD', 'timeFrame': 'From the first measurement before cannulation to the last measurement after 90 days', 'description': 'Fifty patients requiring arterial cannulation were included in this study. Purdue Pegboard scores were measured for fine motor skill assessment of all patients before the procedure. Over three months fine motor skill scores were measured twice more.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Catheterization', 'Regional blood flow', 'Fine motor skills'], 'conditions': ['Radial Artery', 'Ultrasound', 'Fine Motor Skills']}, 'referencesModule': {'references': [{'pmid': '10433393', 'type': 'BACKGROUND', 'citation': 'Desrosiers J, Hebert R, Bravo G, Rochette A. Age-related changes in upper extremity performance of elderly people: a longitudinal study. Exp Gerontol. 1999 Jun;34(3):393-405. doi: 10.1016/s0531-5565(99)00018-2.'}, {'pmid': '8826723', 'type': 'BACKGROUND', 'citation': 'Taneja K, Jain R, Sawhney S, Rajani M. Occlusive arterial disease of the upper extremity: colour Doppler as a screening technique and for assessment of distal circulation. Australas Radiol. 1996 Aug;40(3):226-9. doi: 10.1111/j.1440-1673.1996.tb00391.x.'}, {'pmid': '25516161', 'type': 'BACKGROUND', 'citation': 'Numaguchi A, Adachi YU, Aoki Y, Ishii Y, Suzuki K, Obata Y, Sato S, Nishiwaki K, Matsuda N. Radial artery cannulation decreases the distal arterial blood flow measured by power Doppler ultrasound. J Clin Monit Comput. 2015 Oct;29(5):653-7. doi: 10.1007/s10877-014-9648-5. Epub 2014 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'The present study aims to investigate hemodynamic changes in radial and ulnar artery blood flow following radial artery cannulation performed in elective surgical cases under operating room conditions using Doppler ultrasonography. Additionally, it aims to evaluate the long-term impact of this procedure on vascular flow parameters and fine motor function.', 'detailedDescription': 'This prospective self controlled study included 50 patients aged 18-80 years with an ASA physical status of 1-3 who required arterial cannulation for planned surgical procedures in the cardiovascular surgery operating rooms of Pamukkale University Faculty of Medicine. Before the procedure, radial and ulnar artery Doppler parameters (peak systolic velocity, end-diastolic velocity, resistance index, pulsatility index, and mean volume flow) were measured for all patients, along with Purdue Pegboard scores for fine motor skill assessment. Post-cannulation Doppler parameters were evaluated at seven different time points over three months, while fine motor skill scores were measured twice more during follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing surgical intervention at Pamukkale University Faculty of Medicine, Department of Cardiovascular Surgery, between June and September 2016. Patients aged 18 to 80 years, scheduled for elective surgery, and with an indication for radial artery cannulation were included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nindication for radial artery cannulation\n\nExclusion Criteria:\n\nemergency surgery inadequate collateral blood flow'}, 'identificationModule': {'nctId': 'NCT06975566', 'briefTitle': 'Long-term Effects of Radial Artery Cannulation on Vessel Diameter, Blood Flow and Fine Motor Skills', 'organization': {'class': 'OTHER', 'fullName': 'Kartal City Hospital'}, 'officialTitle': 'Long-term Effects of Radial Artery Cannulation on Vessel Diameter, Blood Flow and Fine Motor Skills', 'orgStudyIdInfo': {'id': 'radial artery study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'radial artery catheterization', 'type': 'PROCEDURE'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kartal City Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'anesthesiology and reanimation specialist, intensive care subspecialist', 'investigatorFullName': 'AKIN BİLİR', 'investigatorAffiliation': 'Kartal City Hospital'}}}}