Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:54 AM
Study NCT ID:
NCT07489859
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurse vs Physician Artery Cannulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 560}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First successful attempt', 'timeFrame': "From the first puncture of the patient's skin until the end of catheterization for maximum time of 20 minutes", 'description': 'Number of first successful attempt'}], 'secondaryOutcomes': [{'measure': 'Time to complete catheterization', 'timeFrame': "From the first puncture of the patient's skin until the end of catheterization for maximum time of 20 minutes", 'description': "Time from firs puncture of a patient's skin to complete successful catheter insertion."}, {'measure': 'Complication rate', 'timeFrame': "From the first puncture of the patient's skin until the extraction of the catheter for maximum time of 7 days", 'description': 'Number of complications related to radial artery catheterization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['education', 'nurse comeptency', 'arterial cathetrization', 'seldinger method', 'competency based education', 'simulation based medical education'], 'conditions': ['Educational Problems', 'Catherization', 'Education Nursing', 'Simulation Based Medical Education']}, 'descriptionModule': {'briefSummary': 'This prospective controlled clinical trial evaluates the effectiveness and safety of radial artery cannulation using the Seldinger technique under ultrasound guidance when performed by two different operator groups: experienced physicians and trained registered nurses. The study aims to determine whether a structured, competency-based training program enables nurses without prior experience in arterial cannulation to achieve comparable outcomes to physicians in terms of first-attempt success rate, procedural efficiency, and complication rates.', 'detailedDescription': 'This study is a prospective, controlled clinical trial designed to compare the performance of radial artery cannulation using the Seldinger technique under ultrasound guidance between two predefined operator groups: experienced physicians and trained registered nurses. The trial is conducted in tertiary-care hospital settings in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. \n\nRadial artery cannulation is a commonly performed invasive procedure used for continuous blood pressure monitoring and arterial blood sampling in perioperative and critical care settings. While traditionally performed by physicians, task-sharing strategies supported by structured training programs may expand procedural capacity while maintaining patient safety. \n\nIn this study, physicians in the control group are board-certified anaesthesiologists or intensivists with established experience in arterial cannulation. The intervention group consists of registered nurses who have no prior experience with arterial cannulation but have successfully completed a structured, competency-based educational program. This program incorporates theoretical instruction, simulation-based training, and supervised clinical practice, based on principles of deliberate practice and mastery learning. \n\nAll procedures are performed using a standardized Seldinger technique with ultrasound guidance and identical equipment, under uniform clinical conditions. Patient preparation, sterile technique, and procedural protocols are standardized across both groups. A supervising physician is immediately available during all procedures to ensure patient safety. \n\nThe primary outcome is first-attempt success rate, defined as successful arterial cannulation following a single skin puncture with confirmation by arterial waveform. Secondary outcomes include total procedure time, overall success rate, number of attempts, and incidence of complications such as hematoma, catheter dysfunction, distal ischemia, and need for rescue intervention. \n\nThe study aims to determine whether nurses trained through a structured educational program can achieve procedural outcomes comparable to experienced physicians. The findings may support the implementation of competency-based training pathways and task-sharing models in vascular access procedures, potentially improving healthcare efficiency while maintaining high standards of patient safety. '}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nurse with successful completion of the predefined radial artery catheterization educational module\n* Czech board certified anaesthesiologist with obtained competency for radial artery catheterization.\n\nExclusion Criteria:\n\n* Absence of competency for radial artery catheterization.'}, 'identificationModule': {'nctId': 'NCT07489859', 'acronym': 'ARTEDU', 'briefTitle': 'Nurse vs Physician Artery Cannulation', 'organization': {'class': 'OTHER', 'fullName': 'Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.'}, 'officialTitle': 'Nurse-performed Versus Physician-performed Radial Artery Cannulation: a Multicenter Randomized Non-inferiority Trial', 'orgStudyIdInfo': {'id': 'ARTEDU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nurse', 'description': 'Cannulation of a radial artery is done by nurse.', 'interventionNames': ['Procedure: Radial artery cathetrization done by nurse']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physician', 'description': 'Cannulation of a radial artery is done by physician.', 'interventionNames': ['Procedure: Radial artery cathetrization done by physician']}], 'interventions': [{'name': 'Radial artery cathetrization done by nurse', 'type': 'PROCEDURE', 'description': 'Cannulation of a radila artery using Seldinger method by nurse.', 'armGroupLabels': ['Nurse']}, {'name': 'Radial artery cathetrization done by physician', 'type': 'PROCEDURE', 'description': 'Cannulation of a radial artery using Seldinger method by physician.', 'armGroupLabels': ['Physician']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'The data will be available after publishing the study. The data will be available for 10 years.', 'ipdSharing': 'YES', 'accessCriteria': 'Data will be accessible publicly in university data repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'deputy for science and research', 'investigatorFullName': 'Michal Kalina', 'investigatorAffiliation': 'Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.'}}}}