3D Printed Silicone Coronary Artery Simulator for Percutaneous Coronary Interventional Training
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change of the time taken in operation
研究概览
简要总结
This study is aim to evaluate the feasibility and effectiveness of 3D printed silicone coronary artery simulator for percutaneous coronary interventional training.
详细描述
With the aging of the population, the incidence of cardiovascular diseases has exceeded that of respiratory diseases and cancer, corresponding to the rapid increase in the number of coronary stent implantation. Therefore, the standardized training of interventional cardiologists is particularly important. Nowadays percutaneous coronary intervention (PCI) training mode is mainly for the trainees to operate on the patients under the experienced operator. Although this kind of training method can truly show the operation process, it has obvious limitations. For beginners, it takes repeated training and revision to achieve proficiency and accuracy.Learning only through real surgery may result in longer operative times, increased radiation exposure, and increased complications.This study is aim to evaluate the feasibility and effectiveness of 3D printed silicone coronary artery simulator for percutaneous coronary interventional training.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previous experience in coronary intervention
- •Understand the process of trail and be willing to participate
排除标准
- •No previous experience with coronary intervention
- •Unwilling to participate the trail
- •Unable to complete the trail due to other problems
结局指标
主要结局
Change of the time taken in operation
时间窗: Through study completion, an average of 4 hours
The change of time taken to complete the coronary angiography assessment before and after training
Change of the amount of contrast agent used
时间窗: Through study completion, an average of 4 hours
The change of the amount of contrast agent used in the coronary angiography assessment before and after training
Change in assessment scores
时间窗: Through study completion, an average of 4 hours
The change of scores of "Rating scale of coronary angiography operation assessment" before and after training. The assessment includes operation integrity, standardization, proficiency, accuracy,etc. Every point contain 5 different levels from the worst(1) to the best(5).
次要结局
未报告次要终点
研究者
Shubin_Qiao
Director,Head of cardiology department
Fu Wai Hospital, Beijing, China