跳至主要内容
临床试验/NCT04285944
NCT04285944Unknown不适用

Operator Radiation Protection During Cardiac Catheterization Using Mavig X-ray Protective Drapes®.

Universitaire Ziekenhuizen KU Leuven3 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
3
主要终点
Operator radiation dose

研究概览

简要总结

Interventional cardiologists are exposed to significant doses of scatter radiation during cardiac catheterization and percutaneous coronary intervention. Traditional methods of reducing the radiation dose for operators in the cardiac catheterization laboratory include limiting the use of radiation, radiation protection aprons and shields, and the use of lead eye glasses. Despite these measures several parts of the operators body, including the head and neck, are poorly screened from scatter radiation. Radiation protection drapes have been developed for use in cardiac catheterization but no randomized controlled study has yet been performed with the commercially available Mavig X-ray Protective Drapes®. The aim of this study is to evaluate operator radiation protection using Mavig X-ray Protective Drapes®.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Patient undergoing the procedure is older than 18 years and is planned for a coronary angiogram, cardiac catheterization and/or percutaneous coronary intervention.
  • The coronary angiogram/cardiac catheterization/PCI procedure is elective.
  • The patient undergoing the procedure is male, or if female, has no childbearing potential or is not pregnant.

排除标准

  • The procedure is an emergency and/or the patient is unstable. -

结局指标

主要结局

Operator radiation dose

时间窗: Immediate

Gray

次要结局

未报告次要终点

研究者

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

Prof Dr Walter Desmet

Professor

Universitaire Ziekenhuizen KU Leuven

研究点 (3)

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