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)

BACKGROUND: The technique of arteriovenous fistula (AVF) puncture is currently taught by colleagues within hemodialysis units. Even if the main principles of the technique are well known and common to all hemodialysis units, strong rationales are still missing to standardize fine practices such as the relative position of the needles, the angle of the needle at puncture, and the position of the bevel at the time of puncture and after the needle is in the vascular lumen. METHODS: We are conducting a prospective, comparative, center-randomized, multicenter study involving 8 hemodialysis centers. The primary objective is to compare the number of adverse events related to AVF puncture between a group receiving theoretical training plus simulation-based training (4 centers) and a group receiving only theoretical training (4 centers). The study will include all adult patients who are scheduled to have an AVF puncture performed by a hemodialysis-trained nurse during a scheduled chronic dialysis session. DISCUSSION: We hypothesize that a training program for nurses on the AVF approach in procedural simulation versus theoretical input alone would decrease the adverse events related to AVF punctures and would be beneficial for the patient. This study is innovative for several reasons. First, simulation-based training in continuing education among professionals is not widely used. Furthermore, training allows for the standardization of practices within the team, both technically and relationally. TRIAL REGISTRATION: ClinicalTrials.gov NCT05302505. Registered on March 17, 2022.