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Clinical Trial NCT05302505 (SIMFAV2) for Nursing Caries, Arteriovenous Fistula, Simulation-based Training is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Simulation-based Training for Nurses and Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients (SIMFAV2)

Recruiting
Clinical Trial NCT05302505 (SIMFAV2) is an interventional study for Nursing Caries, Arteriovenous Fistula, Simulation-based Training that is recruiting. It started on September 5, 2022 with plans to enroll 9,600 participants. Led by University Hospital, Caen, it is expected to complete by September 30, 2024. The latest data from ClinicalTrials.gov was last updated on May 29, 2024.
Brief Summary
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.

Detailed Description
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.

Official Title

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.

Conditions
Nursing CariesArteriovenous FistulaSimulation-based Training
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • SIMFAV2
  • 2021-A01813-38
NCT ID Number
Start Date (Actual)
2022-09-05
Last Update Posted
2024-05-29
Completion Date (Estimated)
2024-09-30
Enrollment (Estimated)
9,600
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSimulation
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
No InterventionControl
Theoretical training for nurses in e-learning on : * arteriovenous fistula puncture * use of ultrasound with echoreferencing and ultrasound guidance * therapeutic communication
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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
Study Central Contact
Contact: Erwan Guillouët, +33231063403, [email protected]
Contact: Clémence Tomadesso, +33231063106, [email protected]
9 Study Locations in 1 Countries
Center hospital of Alençon, Alençon, 61000, France
Erick Cardineau, MD, Contact, 02 33 32 30 30, [email protected]
Not yet recruiting
University hospital center of Caen, Caen, 14000, France
Erwan Guillouët, Contact, [email protected]
Recruiting
Private Hospital St Martin, Caen, 14050, France
Anaïs BENABED, MD, Contact, 0 826 46 14 00
Not yet recruiting
Center Hospital of Dieppe, Dieppe, 76200, France
EMMANUELLE HECQUET, MD, Contact, 0232147248, [email protected]
Not yet recruiting
Center Hospital of Flers, Flers, 61104, France
Victor GUEUTIN, MD, Contact, 02 31 06 31 06, [email protected]
Not yet recruiting
ANIDER, Hérouville-Saint-Clair, 14200, France
PATRICK HENRI, MD, Contact, 02 31 46 97 97, [email protected]
Recruiting
Center Hospital of Lisieux, Lisieux, 14100, France
Loay Al Moussalla, MD, Contact, 02 31 61 31 55, [email protected]
Not yet recruiting
Anider Alencon, Saint-Germain-du-Corbéis, 61000, France
Jean Pierre DIONE, MD, Contact, 0233323097, [email protected]
Recruiting
Center Hospital of Memorial United States of St Lo, Saint-Lô, 50000, France
Elie ZAGDOUN, MD, Contact, 02 33 06 33 33, [email protected]
Recruiting