NCT05302505

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

May 1, 2026

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

March 2, 2022

Last Update Submit

April 27, 2026

Conditions

Nursing CariesArteriovenous FistulaSimulation-based Training

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Simulation

EXPERIMENTAL

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

Control

NO INTERVENTION

Theoretical training for nurses in e-learning on : * arteriovenous fistula puncture * use of ultrasound with echoreferencing and ultrasound guidance * therapeutic communication

Interventions

simulation-based trainingOTHER

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

Simulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Center hospital of Alençon

Alençon, 61000, France

Location

University hospital center of Caen

Caen, 14000, France

Location

Private Hospital St Martin

Caen, 14050, France

Location

Center Hospital of Dieppe

Dieppe, 76200, France

Location

Center Hospital of Flers

Flers, 61104, France

Location

ANIDER

Hérouville-Saint-Clair, 14200, France

Location

Center Hospital of Lisieux

Lisieux, 14100, France

Location

Anider Alencon

Saint-Germain-du-Corbéis, 61000, France

Location

Center Hospital of Memorial United States of St Lo

Saint-Lô, 50000, France

Location

Related Publications (1)

  • Guillouet E, Tomadesso C, Flores BA, Henri P, Lanot A, Morello R, Guillouet S. Impact of simulation-based training in addition to theoretical training versus theoretical training of nurses alone in the occurrence of adverse events related to arteriovenous fistula puncture in chronic hemodialysis patients: study for a cluster randomized controlled trial (SIMFAV2). Trials. 2023 Aug 7;24(1):500. doi: 10.1186/s13063-023-07513-8.

    PMID: 37550740DERIVED

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Erwan Guillouët

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 31, 2022

Study Start

September 5, 2022

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

May 1, 2026

Record last verified: 2024-05

Locations

FR(9)