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

Nursing Caries Clinical Trial

— SIMFAV2  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05302505
• Other study ID #: 2021-A01813-38
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Caen
• Contact: Erwan Guillouët
• Phone: +33231063403
• Email: guillouet-e[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9600
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula
• Nursing Caries
• Simulation-based Training

Intervention

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

Locations

Country	Name	City	State
France	Center hospital of Alençon	Alençon
France	Private Hospital St Martin	Caen
France	University hospital center of Caen	Caen
France	Center Hospital of Dieppe	Dieppe
France	Center Hospital of Flers	Flers
France	ANIDER	Hérouville-Saint-Clair
France	Center Hospital of Lisieux	Lisieux
France	Anider Alencon	Saint-Germain-du-Corbéis
France	Center Hospital of Memorial United States of St Lo	Saint-Lô

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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