Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-29 @ 7:21 AM
Study NCT ID:
NCT05258903
Status:
UNKNOWN
Last Update Posted:
2023-07-27
First Post:
2022-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ulnar Artery Versus Radial Artery Cannulation in Paediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'randomization after general anesthesia induction, or deep sedation in PICU'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Non-inferiority randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2022-02-17', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall puncture success in different arterial sites', 'timeFrame': 'intraoperatively', 'description': 'defined by number of required percutaneous punctures and overall site success rate'}], 'secondaryOutcomes': [{'measure': 'Arteries anatomical description', 'timeFrame': 'intraoperatively', 'description': 'Defined by USG measurement of depth of the artery - (distance from the skin to the upper wall of the artery), cross-sectional area, diameter of the artery.'}, {'measure': 'Technique of the ultrasound-guided cannulation (in-plane/out-of-plane)', 'timeFrame': 'intraoperatively', 'description': 'The USG guidance approach will be evaluated'}, {'measure': 'Incidence of complications', 'timeFrame': '24 hours postoperatively', 'description': 'Blood supply disorder, trophic changes, hematoma, arterial wall injury (aneurysm etc.), thrombosis.'}, {'measure': 'Duration of catheterization', 'timeFrame': 'Intraoperatively', 'description': 'Time needed for successful catheterization'}, {'measure': 'Interval between catheterization and catheter removal', 'timeFrame': '24 hours postoperatively', 'description': 'Interval between catheterization and catheter removal will be evaluated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric anesthesia', 'pediatric patient', 'Arterial catheterization', 'arterial catheter', 'ultrasound-guided cannulation', 'Arterial cannulation'], 'conditions': ['Arterial Catheterization']}, 'descriptionModule': {'briefSummary': 'Arterial cannulation is indicated in several clinical settings: high-risk surgery, respiratory failure, circulatory failure. The possible anatomical sites of cannulation are: a.radialis, a.brachialis, a. femoralis. However, the most reported complications in preschool-aged children are associated with femoral and brachial arteries. Therefore, alternative cannulation sites are being searched as ulnar artery, tibial posterior artery.', 'detailedDescription': 'In pediatric patients, artery cannulation may be associated with a higher risk of complications. The preferred puncture site is the radial artery or the femoral artery. However, puncture of the femoral artery in comparison with the radial artery is based on observational data as a significant risk side of post-puncture complications. The radial artery is the dominant artery of the hand, and the collateral supply (via the ulnar artery) is often unable to provide adequate peripheral perfusion. Therefore, other potential sites suitable for artery cannulation in paediatric patients are currently being investigated with the primary goal of increasing safety and reducing the risk of post-puncture complications. According to published studies, the potential alternatives are: posterior tibial artery and ulnar artery. Both arteries have comparable dimensions with radial artery and can be used for USG-guided cannulation. In this prospective randomized trial, patients with clinical indication for arterial cannulation (high-risk surgery, respiratory failure, circulatory failure) undergoing surgery under general anesthesia and pediatric patients admitted into the pediatric intensive care unit (PICU) will be randomized in form of sealed envelopes into a.radialis and a.ulnaris group as the initial site of arterial catheterization. Ultrasound (USG) measurement of both arteries will be performed before the cannulation. The catheterization success rate (number of percutaneous punctures) and overall success rate will be evaluated. The artery will be cannulated under USG control, initially in in-plane view, only in case of insufficient image, or after 2 unsuccessful attempts, the out-of-plane approach could be used. The maximum 5 percutaneous attempts and 10 minutes could be used for the initial (randomized) site of cannulation). In case of cannulation failure, the other artery could be used for cannulation. The rate of complications in 24 hours after cannulation will be evaluated. The arterial catheter will stay in place until the clinical indication remained.\n\n.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Paediatric patients (1 - 6 years)\n* high risk surgery (significant blood loss or hemodynamic instability)\n* critically ill patients at PICU (respiratory failure, circulatory failure)\n* informed consent\n\nExclusion Criteria:\n\n* refused to participate\n* arterial catheterization not clinically relevant'}, 'identificationModule': {'nctId': 'NCT05258903', 'acronym': 'ULNART', 'briefTitle': 'Ulnar Artery Versus Radial Artery Cannulation in Paediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Brno University Hospital'}, 'officialTitle': 'Ulnar Artery Versus Radial Artery Cannulation in Paediatric Patients: a Prospective Randomized Non-inferiority Study', 'orgStudyIdInfo': {'id': 'KDAR FN Brno Artery'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ulnar artery', 'description': 'Ulnar artery cannulation under USG-guidance', 'interventionNames': ['Procedure: Ulnar artery cannulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radial artery', 'description': 'Radial artery cannulation under USG-guidance', 'interventionNames': ['Procedure: Radial artery cannulation']}], 'interventions': [{'name': 'Ulnar artery cannulation', 'type': 'PROCEDURE', 'otherNames': ['Ulnar artery catheterization'], 'description': 'Ulnar artery will be cannulated under USG guidance', 'armGroupLabels': ['Ulnar artery']}, {'name': 'Radial artery cannulation', 'type': 'PROCEDURE', 'otherNames': ['Radial artery catheterization'], 'description': 'Radial artery will be cannulated under USG guidance', 'armGroupLabels': ['Radial artery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62500', 'city': 'Brno', 'state': 'South Moravian', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Petr Štourač, assoc.prof.MD.Ph.D.', 'role': 'CONTACT', 'email': 'stourac.petr@fnbrno.cz', 'phone': '532234404', 'phoneExt': '00420'}, {'name': 'Jozef Klučka, MD', 'role': 'CONTACT', 'email': 'klucka.jozef@fnbrno.cz', 'phone': '532234696', 'phoneExt': '00420'}], 'facility': 'Brno University Hospital', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'centralContacts': [{'name': 'Jozef UO Klučka, assoc.prof.MD., Ph.D.', 'role': 'CONTACT', 'email': 'klucka.jozef@fnbrno.cz', 'phone': '+420532234696'}, {'name': 'Václav Vafek, MD', 'role': 'CONTACT', 'email': 'Vafek.Vaclav@fnbrno.cz', 'phone': '+420532234696'}], 'overallOfficials': [{'name': 'Petr Stourac, prof. MD., Ph.D., MBA', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of paediatric anaesthesia and intensive care medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brno University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Masaryk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Petr Štourač, MD', 'investigatorAffiliation': 'Brno University Hospital'}}}}