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Eine Studie entspricht den Filterkriterien
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Simulation-based Training for Nurses and Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients (SIMFAV2)

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05302505 (SIMFAV2) ist eine interventionsstudie zur Untersuchung von Pflegekaries, Arterio-venöse Fistel, Simulationsbasiertes Training und hat den Status offene rekrutierung. Die Studie startete am 5. September 2022 und soll 9.600 Teilnehmer aufnehmen. Durchgeführt von University Hospital, Caen ist der Abschluss für 30. September 2024 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 29. Mai 2024 aktualisiert.
Kurzbeschreibung
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.

The 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.

Ausführliche Beschreibung
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.

The 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.

The 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.

The 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:

  • A group receiving theoretical training + simulation-based training (4 centers)
  • A group receiving theoretical training only (4 centers)

Will 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.

This study is innovative for several reasons:

  • simulation-based training in continuing education, among professionals is not widely used
  • simulation-based training in continuing education allows the conceptualization of the team approach to VF by its modeling in simulation
  • the evaluation of the direct benefit of the training on the patient, a Kirkpatrick level 4, is very little described in the literature.

Thus, this study is of major interest to patients managed in nephrology with the simulation-based training tool.

Offizieller Titel

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.

Erkrankungen
PflegekariesArterio-venöse FistelSimulationsbasiertes Training
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • SIMFAV2
  • 2021-A01813-38
NCT-Nummer
Studienbeginn (tatsächlich)
2022-09-05
Zuletzt aktualisiert
2024-05-29
Studienende (vorauss.)
2024-09-30
Geplante Rekrutierung
9.600
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Andere
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellSimulation
Theoretical training in e-learning for nurses on : * arteriovenous fistula puncture * use of ultrasound with echoreferencing and ultrasound guidance * therapeutic communication And simulation-based training (procedural) on : * arteriovenous fistula puncture * use of ultrasound with echoreferencing and ultrasound guidance * therapeutic communication
Simulation-based Training
Based-simulation training for nurses in a simulation center : puncture of arteriovenous fistula and utilization of echograph and conversational hypnosis
Keine InterventionControl
Theoretical training for nurses in e-learning on : * arteriovenous fistula puncture * use of ultrasound with echoreferencing and ultrasound guidance * therapeutic communication
Nicht zutreffend
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Number of adverse events occurring during arteriovenous fistula puncture (comparison of the percentages of event occurrence)
defined by one of the following events: * Unipuncture failure * Bipuncture failure * Simple hematoma * Hematoma not allowing continued dialysis
45 days
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • Adult patients
  • Arteriovenous fistula puncture in the hemodialysis unit of the nephrology, dialysis, transplantation department
  • Nurses trained in hemodialysis

  • arteriovenous fistula puncture in the emergency area/foldout of the unit
  • Refuse of data collection
  • Not speak French
  • Minor
  • Under guardianship or unable to give informed consent
  • Not enrolled in a social security plan
  • Pregnant or breastfeeding women
University Hospital, Caen logoUniversity Hospital, Caen
Zentrale Studienkontakte
Kontakt: Erwan Guillouët, +33231063403, [email protected]
Kontakt: Clémence Tomadesso, +33231063106, [email protected]
9 Studienstandorte in 1 Ländern
Center hospital of Alençon, Alençon, 61000, France
Erick Cardineau, MD, Kontakt, 02 33 32 30 30, [email protected]
Noch nicht rekrutierend
University hospital center of Caen, Caen, 14000, France
Erwan Guillouët, Kontakt, [email protected]
Offene Rekrutierung
Private Hospital St Martin, Caen, 14050, France
Anaïs BENABED, MD, Kontakt, 0 826 46 14 00
Noch nicht rekrutierend
Center Hospital of Dieppe, Dieppe, 76200, France
EMMANUELLE HECQUET, MD, Kontakt, 0232147248, [email protected]
Noch nicht rekrutierend
Center Hospital of Flers, Flers, 61104, France
Victor GUEUTIN, MD, Kontakt, 02 31 06 31 06, [email protected]
Noch nicht rekrutierend
ANIDER, Hérouville-Saint-Clair, 14200, France
PATRICK HENRI, MD, Kontakt, 02 31 46 97 97, [email protected]
Offene Rekrutierung
Center Hospital of Lisieux, Lisieux, 14100, France
Loay Al Moussalla, MD, Kontakt, 02 31 61 31 55, [email protected]
Noch nicht rekrutierend
Anider Alencon, Saint-Germain-du-Corbéis, 61000, France
Jean Pierre DIONE, MD, Kontakt, 0233323097, [email protected]
Offene Rekrutierung
Center Hospital of Memorial United States of St Lo, Saint-Lô, 50000, France
Elie ZAGDOUN, MD, Kontakt, 02 33 06 33 33, [email protected]
Offene Rekrutierung