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临床试验/NCT05043064
NCT05043064已完成不适用

Validity Evidence for Simulation-based Assessment of Robotic Cardiac Surgical Skills and Examination of Learning Curves in Wet Labs

Aalborg University Hospital2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Time-based Score

研究概览

简要总结

The goal of this study is to investigate validity of the wet lab robotic cardiac surgery model used for training in robotic cardiac surgery and to evaluate learning curves in trainees of different surgical specialities. The investigators hope to recruit experienced robotic cardiac surgeons (experts) and cardiac and non-cardiac surgeons with minimal robotic experience (trainees). Participants will perform three predetermined tasks common in the wet lab robotic cardiac surgery training. Participants will be evaluated at baseline for each task. From experts' performance the mastery learning level will be calculated. Trainees will perform the tasks until mastery is achieved. The investigators will then be able to evaluate validity of the wet lab model and analyze learning curves in all participants by rating their performance.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

All tasks will be recorded and evaluated blinded using the modified Global Evaluative Assessment of Robotic Skills (mGEARS) score by two not participating raters

入排标准

性别
All
接受健康志愿者

入选标准

  • Experienced robotic cardiac surgeons: robotic surgeons with total volume > 50 robotic cardiac operations and at least 20 robotic cases annually
  • Cardiac surgeons with limited robotic experience (robotic novices): on-going or completed cardio-thoracic residency
  • Non-cardiac surgeons with limited robotic experience (robotic novices): on-going or completed surgical specialty residency (general surgery, urology, gynaecology, ENT surgery)

排除标准

  • Robotic novices with > 5 hours experience of any robotic system

结局指标

主要结局

Time-based Score

时间窗: 6 months

The time-based score (TBS) was calculated as follows: TBS = maximal total training time per task - actual completion time - errors. Units of measure - seconds. Minimum score 0, Maximum score 1222. TBS was calculated in seconds, where 0 was the lowest score and a higher number indicated a faster time to perform the task. The score range

次要结局

  • Modified Global Evaluative Assessment of Robotic Skills (mGEARS)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gennady Atroshchenko

Principal Investigator

Aalborg University Hospital

研究点 (2)

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