跳至主要内容
临床试验/NCT05833516
NCT05833516已完成不适用

Operator Radiation Exposure in Hyper Adduction of Right Radial Artery/Arm vs Left Arm Drag Over Technique.

Maimonides Medical Center1 个研究点 分布在 1 个国家目标入组 534 人开始时间: 2022年11月10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
534
试验地点
1
主要终点
Normalized Dose

研究概览

简要总结

Several studies have shown that operator exposure via left transradial catheterization has yielded less operator exposure compared to standard right transradial procedure. However, in light of new data, the investigators hypothesize a hyperadducted right arm during right transradial cardiac catheterization will yield comparable, or the same operator radiation exposure.

详细描述

Few studies have examined operator's radiation exposure tor transradial cardiac catheterization between the left vs right radial artery approach. In light of recent studies (Schiabasi et al) demonstrating adduction of the right arm yields lower operator exposure than that of the right arm positioned away from the body to the operators. The investigators seek to examine if hyper adduction of the right arm yields similar operator exposure to that of the left radial approach.

Historically the left radial approach has been more favorable in terms of operator exposure. However, the primary access site for interventional cardiologists has been the right radial artery due to cardiac catheterization laboratories set up for operators to work on the right side of the table. This study seeks to find if a hyperadducted right arm yields less, more, or similar radiation exposure to the operator in cardiac catheterization laboratory than the left radial artery approach.

This study's primary outcome is to measure the radiation exposure to the primary operator during diagnostic cardiac catheterization at four different anatomical locations (these are Maimonides Medical Center employees -attending physicians in the catheterization lab). Study's secondary outcomes aim to measure Dose Area Product, mGy of radiation dose, & contrast administration to the patients undergoing the procedure and presence/absence of subclavian artery tortuosity which are recorded automatically and regardless during the diagnostic procedure.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • All the Cardiac catheterization laboratory physician operators who consent to participate in the study
  • Patients of any sex and gender.
  • Age > 18 years old.
  • Patients undergoing diagnostic coronary angiogram from in-patient and out-patient settings

排除标准

  • History of prior CABG (Coronary Artery Bypass Surgery). CABG patients will be excluded due to inherent increased fluoroscopic time (finding grafts).
  • Patients undergoing elective PCI (Percutaneous Coronary Intervention)

结局指标

主要结局

Normalized Dose

时间窗: During Cardiac Catheterization

The second primary endpoint is Normalized dose, measured by dividing cumulative dose by dose area product (CD/DAP) and entered into query sheet then logged into an Excel spreadsheet.

Operator radiation exposure

时间窗: During Cardiac Catheterization

The primary operators will wear real time radiation dose monitoring at the left eye, right eye, thorax and abdomen level. At the end of each diagnostic procedure the cumulative radiation dose (measured in µSv) data at each level will be collected

次要结局

  • Flouroscopy time(During Cardiac Catheterization)
  • Dose Area product (DAP)(During Cardiac Catheterization)
  • mGy(During Cardiac Catheterization)
  • Subclavian tortuosity (Yes/no)(During Cardiac Catheterization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验