跳至主要内容
临床试验/NCT05302505
NCT05302505已完成不适用

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.

University Hospital, Caen18 个研究点 分布在 1 个国家目标入组 9,600 人开始时间: 2022年9月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9,600
试验地点
18
主要终点
Number of adverse events occurring during arteriovenous fistula puncture (comparison of the percentages of event occurrence)

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • arteriovenous fistula puncture in the emergency area/foldout of the unit
  • Refuse of data collection
  • Not speak French
  • Under guardianship or unable to give informed consent
  • Not enrolled in a social security plan
  • Pregnant or breastfeeding women

研究组 & 干预措施

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

干预措施: simulation-based training (Other)

Control

No Intervention

Theoretical training for nurses in e-learning on :

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

结局指标

主要结局

Number of adverse events occurring during arteriovenous fistula puncture (comparison of the percentages of event occurrence)

时间窗: 45 days

defined by one of the following events: * Unipuncture failure * Bipuncture failure * Simple hematoma * Hematoma not allowing continued dialysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (18)

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