Simulation-based Training for Nurses and Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients (SIMFAV2)

July 6, 2023 updated by: University Hospital, Caen

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

9600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Alençon, France, 61000
        • Not yet recruiting
        • Center hospital of Alençon
        • Contact:
      • Caen, France, 14000
      • Caen, France, 14050
        • Not yet recruiting
        • Private Hospital St Martin
        • Contact:
          • Anaïs BENABED, MD
          • Phone Number: 0 826 46 14 00
      • Dieppe, France, 76200
        • Not yet recruiting
        • Center Hospital of Dieppe
        • Contact:
      • Flers, France, 61104
        • Not yet recruiting
        • Center Hospital of Flers
        • Contact:
      • Hérouville-Saint-Clair, France, 14200
        • Recruiting
        • ANIDER
        • Contact:
      • Lisieux, France, 14100
        • Not yet recruiting
        • Center Hospital of Lisieux
        • Contact:
      • Saint-Germain-du-Corbéis, France, 61000
        • Recruiting
        • Anider Alencon
        • Contact:
      • Saint-Lô, France, 50000
        • Recruiting
        • Center Hospital of Memorial United States of St Lo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients
  • Arteriovenous fistula puncture in the hemodialysis unit of the nephrology, dialysis, transplantation department
  • Nurses trained in hemodialysis

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simulation

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
Other: simulation-based training
Based-simulation training for nurses in a simulation center : puncture of arteriovenous fistula and utilization of echograph and conversational hypnosis
No Intervention: Control

Theoretical training for nurses in e-learning on :

  • arteriovenous fistula puncture
  • use of ultrasound with echoreferencing and ultrasound guidance
  • therapeutic communication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events occurring during arteriovenous fistula puncture (comparison of the percentages of event occurrence)
Time Frame: 45 days

defined by one of the following events:

  • Unipuncture failure
  • Bipuncture failure
  • Simple hematoma
  • Hematoma not allowing continued dialysis
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Erwan Guillouët, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2022

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A01813-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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