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临床试验/NCT03812926
NCT03812926已完成不适用

Compuflo® Assisted Training vs Conventional Training for the Identification of the Ligamentum Flavum With an Epidural Simulator

European e-Learning School in Obstetric Anesthesia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
epidural attempts

研究概览

简要总结

Epidural block is one of the most difficult skills that can be mastered by trainees probably due to the difficulty of recognizing the ligamentum flavum (LF) during the loss of resistance technique (LORT).The CompuFlo® Instrument can measure the pressure of human tissues in real-time at the orifice of a needle and it has been successfully used in clinical practice to identify the epidural space.The aim of this study was to evaluate whether Compuflo® may help trainees to identify the ligamentum flavum using a realistic Epidural Simulator

详细描述

The investigators enrolled 60 trainees who have never performed an epidural block. After having had a standardized learning module on epidural anatomy and technique, each trainee practiced the epidural and the Compuflo®-assisted LORT on the simulator for a maximum of 5 attemps. Trainees were asked to stop the needle entrance whenever they felt a sensation of an increase of resistance due to the penetration of the needle in the LF. The correct position of the needle was verified by an expert instructor. The number of attempts was noted. The power analysis required a sample size of 60 observations to set 80% test power and a 95% significance. Unpaired T-test was used to evaluate the differences in the number of epidural attempts. A logistic regression model was used to correlate the "success at the first attempt ratio" and the technique used.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
26 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • First year trainees in anesthesia who never have performed an epidural block

排除标准

  • 未提供

结局指标

主要结局

epidural attempts

时间窗: 10 minutes

number of attempts to correctly identify the epidural space

次要结局

未报告次要终点

研究者

发起方
European e-Learning School in Obstetric Anesthesia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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