Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT05302505
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2022-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Simulation-based Training for Nurses and Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2022-03-02', 'studyFirstSubmitQcDate': '2022-03-21', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events occurring during arteriovenous fistula puncture (comparison of the percentages of event occurrence)', 'timeFrame': '45 days', 'description': 'defined by one of the following events:\n\n* Unipuncture failure\n* Bipuncture failure\n* Simple hematoma\n* Hematoma not allowing continued dialysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nursing Caries', 'Arteriovenous Fistula', 'Simulation-based Training']}, 'referencesModule': {'references': [{'pmid': '37550740', 'type': 'DERIVED', 'citation': 'Guillouet E, Tomadesso C, Flores BA, Henri P, Lanot A, Morello R, Guillouet S. Impact of simulation-based training in addition to theoretical training versus theoretical training of nurses alone in the occurrence of adverse events related to arteriovenous fistula puncture in chronic hemodialysis patients: study for a cluster randomized controlled trial (SIMFAV2). Trials. 2023 Aug 7;24(1):500. doi: 10.1186/s13063-023-07513-8.'}]}, 'descriptionModule': {'briefSummary': 'Currently, the technique of arteriovenous fistula puncture is transmitted by companionship within hemodialysis units. Although the main principles of the technique are well known and common to all hemodialysis units, strong rationales are still lacking to standardize fine practices such as the relative position of the needles, the angle of attack of the needle at puncture, the position of the bevel at the time of puncture and once the needle is in the vascular lumen.\n\nThe training of professionals using a simulation-based training program on the approach to arteriovenous fistula puncture, in a process of optimizing practices and continuous improvement of care, while respecting the principles of andragogy, seems to be a suitable tool. This program is built in a multi-professional team from nephrology, nursing and health simulation.', 'detailedDescription': 'Currently, the technique of arteriovenous fistula puncture is transmitted by companionship within hemodialysis units. Although the main principles of the technique are well known and common to all hemodialysis units, strong rationales are still lacking to standardize fine practices such as the relative position of the needles, the angle of attack of the needle at puncture, the position of the bevel at the time of puncture and once the needle is in the vascular lumen.\n\nThe training of professionals using a simulation-based training program on the approach to arteriovenous fistula puncture, in a process of optimizing practices and continuous improvement of care, while respecting the principles of andragogy, seems to be a suitable tool. This program is built in a multi-professional team from nephrology, nursing and health simulation.\n\nThe aim of this study is to evaluate whether a simulation-based training program for nurses, concerning arteriovenous fistula puncture puncture, would allow to decrease the adverse events related to punctures.\n\nThe investigators propose a prospective, comparative, randomized, multicenter study involving 8 hemodialysis centers. The primary objective is to compare the number of arteriovenous fistula puncture-related adverse events between:\n\n* A group receiving theoretical training + simulation-based training (4 centers)\n* A group receiving theoretical training only (4 centers)\n\nWill be included all adult patients who are to receive an arteriovenous fistula puncture puncture by a hemodialysis-trained IDE, during a scheduled chronic dialysis session.\n\nThis study is innovative for several reasons:\n\n* simulation-based training in continuing education, among professionals is not widely used\n* simulation-based training in continuing education allows the conceptualization of the team approach to VF by its modeling in simulation\n* the evaluation of the direct benefit of the training on the patient, a Kirkpatrick level 4, is very little described in the literature.\n\nThus, this study is of major interest to patients managed in nephrology with the simulation-based training tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\n* Arteriovenous fistula puncture in the hemodialysis unit of the nephrology, dialysis, transplantation department\n* Nurses trained in hemodialysis\n\nExclusion Criteria:\n\n* arteriovenous fistula puncture in the emergency area/foldout of the unit\n* Refuse of data collection\n* Not speak French\n* Minor\n* Under guardianship or unable to give informed consent\n* Not enrolled in a social security plan\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT05302505', 'acronym': 'SIMFAV2', 'briefTitle': 'Simulation-based Training for Nurses and Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Impact of Simulation-based Training in Addition to Theoretical Training Versus Theoretical Training Alone for Nurses on the Occurring of Adverse Events Related to Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients.', 'orgStudyIdInfo': {'id': '2021-A01813-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simulation', 'description': 'Theoretical training in e-learning for nurses on :\n\n* arteriovenous fistula puncture\n* use of ultrasound with echoreferencing and ultrasound guidance\n* therapeutic communication\n\nAnd simulation-based training (procedural) on :\n\n* arteriovenous fistula puncture\n* use of ultrasound with echoreferencing and ultrasound guidance\n* therapeutic communication', 'interventionNames': ['Other: simulation-based training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Theoretical training for nurses in e-learning on :\n\n* arteriovenous fistula puncture\n* use of ultrasound with echoreferencing and ultrasound guidance\n* therapeutic communication'}], 'interventions': [{'name': 'simulation-based training', 'type': 'OTHER', 'description': 'Based-simulation training for nurses in a simulation center : puncture of arteriovenous fistula and utilization of echograph and conversational hypnosis', 'armGroupLabels': ['Simulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61000', 'city': 'Alençon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Erick Cardineau, MD', 'role': 'CONTACT', 'email': 'ecardineau@ch-alencon.fr', 'phone': '02 33 32 30 30'}], 'facility': 'Center hospital of Alençon', 'geoPoint': {'lat': 48.43476, 'lon': 0.09311}}, {'zip': '14000', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Erwan Guillouët', 'role': 'CONTACT', 'email': 'guillouet-e@chu-caen.fr'}], 'facility': 'University hospital center of Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '14050', 'city': 'Caen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anaïs BENABED, MD', 'role': 'CONTACT', 'phone': '0 826 46 14 00'}], 'facility': 'Private Hospital St Martin', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '76200', 'city': 'Dieppe', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'EMMANUELLE HECQUET, MD', 'role': 'CONTACT', 'email': 'ehecquet@ch-dieppe.fr', 'phone': '0232147248'}], 'facility': 'Center Hospital of Dieppe', 'geoPoint': {'lat': 49.9216, 'lon': 1.07772}}, {'zip': '61104', 'city': 'Flers', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Victor GUEUTIN, MD', 'role': 'CONTACT', 'email': 'gueutin-v@chu-caen.fr', 'phone': '02 31 06 31 06'}], 'facility': 'Center Hospital of Flers', 'geoPoint': {'lat': 48.73722, 'lon': -0.57466}}, {'zip': '14200', 'city': 'Hérouville-Saint-Clair', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'PATRICK HENRI, MD', 'role': 'CONTACT', 'email': 'henri-p@chu-caen.fr', 'phone': '02 31 46 97 97'}], 'facility': 'ANIDER', 'geoPoint': {'lat': 49.21088, 'lon': -0.30653}}, {'zip': '14100', 'city': 'Lisieux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Loay Al Moussalla, MD', 'role': 'CONTACT', 'email': 'I.almoussalla@ch-lisieux.fr', 'phone': '02 31 61 31 55'}], 'facility': 'Center Hospital of Lisieux', 'geoPoint': {'lat': 49.1466, 'lon': 0.22925}}, {'zip': '61000', 'city': 'Saint-Germain-du-Corbéis', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Pierre DIONE, MD', 'role': 'CONTACT', 'email': 'jpdione@ch-alencon.fr', 'phone': '0233323097'}], 'facility': 'Anider Alencon', 'geoPoint': {'lat': 48.42215, 'lon': 0.06193}}, {'zip': '50000', 'city': 'Saint-Lô', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elie ZAGDOUN, MD', 'role': 'CONTACT', 'email': 'elie.zagdoun@ch-stlo.fr', 'phone': '02 33 06 33 33'}], 'facility': 'Center Hospital of Memorial United States of St Lo', 'geoPoint': {'lat': 49.11624, 'lon': -1.09031}}], 'centralContacts': [{'name': 'Erwan Guillouët', 'role': 'CONTACT', 'email': 'guillouet-e@chu-caen.fr', 'phone': '+33231063403'}, {'name': 'Clémence Tomadesso', 'role': 'CONTACT', 'email': 'tomadesso-c@chu-caen.fr', 'phone': '+33231063106'}], 'overallOfficials': [{'name': 'Erwan Guillouët', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}