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Completed

NCT Number: NCT05302505

Simulation-based Training for Nurses and 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center hospital of Alençon, Alençon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simulation-based training

Other

Based-simulation training for nurses in a simulation center : puncture of arteriovenous fistula and utilization of echograph and conversational hypnosis

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study 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.

Acronym: SIMFAV2

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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