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临床试验/NCT05722080
NCT05722080招募中不适用

E3CAPS: Improvement of the Safety of Care in Cataract Surgery Teaching on Eyesi Simulator: Learning Curve and Impact of Sleep Deprivation on Residents in Ophthalmology

Nantes University Hospital4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
4
主要终点
Scores on standardized simulator Eyesi assessments

研究概览

简要总结

The aim of this project is to reduce the risks of cataract surgery using the EyeSi simulator Axis 1: to model the learning curve of novice residents in Ophthalmology who follow the training program recommended by the "Collège des Ophtalmologistes niversitaires de France" (COUF) in order to help creating a "licence to operate" Axis 2: to evaluate the impact of sleep deprivation on the surgical performance of experienced residents in Ophthalmology

详细描述

Axis 1 (15 residents): Learning curve Each resident will perform four 2-hour learning sessions, under the supervision of an experienced cataract surgery trainer. Each resident will perform a standardized assessment at the beginning of the first session with the collection of scores at each surgical stage and the calculation of an average score simulating a complete surgery. This standardized assessment will then be repeated at the end of each of the 4 training sessions. These five points of measurement will make it possible to produce a learning curve for each surgical stage and for the average score simulating a complete surgery.

Axis 2 (25 residents): Sleep deprivation

  • 1st session: In order to include the "experienced" residents and to limit the bias related to the learning curve of the cognitive tests and the surgical procedure

  • 3 normed assessments in autonomy to determine the average score for each resident

  • 3 trials of the Test for Attentional Performance (TAP) with parallel versions to limit test-retest learning bias

  • 2nd session: No sleep deprivation

  • Sleep assessment by actimetry the night before the session (MotionWatch 8©, camntech®, validated as an alternative method to the reference method which is polysomnography)

  • Epworth sleepiness score

  • Visual Analogue Scale for Self-Rated Fatigue

  • Attentional performance tests TAP

  • 3 standardized evaluations on Eyesi in the morning and in the afternoon

  • 3rd session: sleep deprivation (< 7 hours) after a working day

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Novice resident in Ophthalmology (Axis 1)
  • Experienced resident in Opthalmology (Axis 2 )

排除标准

  • 未提供

研究组 & 干预措施

simulator Eyesi - new residents

Other

Eyesi simulator learning curve for new ophthalmology residents

干预措施: Eyesi simulator (Other)

simulator Eyesi/sleep deprivation -confirmed residents

Other

See how experienced residents perform after sleep deprivation using the Eyesi simulator

干预措施: Sleep deprivation (Other)

结局指标

主要结局

Scores on standardized simulator Eyesi assessments

时间窗: Change the score from Baseline at 1 year

Average score of standardized evaluations on EyeSi simulator. The scale title is "EyeSi score". The scores range from 0 to 100, better outcome being positively correlated with a higher score

Scores on standardized simulator Eyesi assessments after sleep deprivation

时间窗: Change the score from Baseline at 1 year

Average score of standardized evaluations on EyeSi simulator after sleep deprivation. The scale title is "EyeSi score". The scores range from 0 to 100, better outcome being positively correlated with a higher score

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 (4)

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