跳至主要内容
临床试验/NCT03605030
NCT03605030已完成不适用

Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures With a Novel Lead-Based Arm-Board

London Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2017年5月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
360
试验地点
1
主要终点
Radiation dose (μSv) to the operator at the forearm level

研究概览

简要总结

The primary objective of this study is to determine if a novel lead-based arm board is effective at reducing radiation dose to the operator during invasive cardiac procedures. Secondary objectives are to measure effect on radiation dose to patient and total fluoroscopy (x-ray) time.

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

  • Age > 18
  • Planned invasive cardiology procedure, cardiac catheterization with or without percutaneous coronary intervention (PCI), or PCI alone.

排除标准

  • Inability to provide consent

研究组 & 干预措施

Novel Lead Based Armboard

Active Comparator

干预措施: Novel Lead Based Armboard (Device)

Standard Armboard

Placebo Comparator

干预措施: Standard Armboard (Device)

结局指标

主要结局

Radiation dose (μSv) to the operator at the forearm level

时间窗: At procedure completion

Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.

Radiation dose (μSv) to the operator at the chest

时间窗: At procedure completion

Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.

次要结局

  • Dose area product(At procedure completion)
  • Air kerma(At procedure completion)
  • Radiation dose to the patient(At procedure completion)

研究者

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

Pallav Garg

Assistant Professor

London Health Sciences Centre

研究点 (1)

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