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临床试验/NCT02088788
NCT02088788已完成不适用

Reduction in Physician Radiation Exposure During Radial Access Cardiac Catheterization Using a Radiation Protection Board

Geisinger Clinic2 个研究点 分布在 1 个国家目标入组 265 人开始时间: 2013年6月最近更新:
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
265
试验地点
2
主要终点
Operator Radiation Exposure

研究概览

简要总结

Radiation exposure to operator is an occupational hazard of invasive cardiologists. During radial access for diagnostic catheterization, a new radio-dense arm board is advertised to reduce operator radiation exposure. The investigators randomize patients to a new radio-dense armboard versus a standard radio-transparent armboard during diagnostic catheterization and measure radiation exposure to the operator. Both groups have a radio-dense pelvic shield in place. The investigators hypothesize that operator radiation dose will be decreased by use of the radio-dense armboard.

详细描述

Hypothesis

Compared to standard shielding with a lead pelvic drape alone, using a radio-opaque arm board in addition to the pelvic drape will decrease operator radiation exposure during radial access cardiac catheterization by at least 30%.

STUDY DESIGN This is a randomized, prospective study where patients will be randomized by random numbers in sealed envelopes to standard shielding (pelvic drape alone, the "no-board group") or to experimental shielding (pelvic drape plus radiation board, the "board group").

A robust radiation safety monitoring program is in place. Patient exposure is measured by the catheterization laboratory equipment and recorded. Lindauer Microstar Nanodot badges worn at waist level above the radiation lead will be used to measure operator radiation exposure. A new Nanodot will be used for every case. Radiation exposure to the operator's Nanodot will be measured immediately after each procedure by a technician blinded to study assignment.

All patients 18-89 years old presenting to Geisinger Medical Center for diagnostic cardiac catheterization will be evaluated for the study. All interventional or diagnostic cardiologists and fellows that will be performing the cardiac catheterization procedure also will be study subjects. Approximately 215 Geisinger patients who satisfy inclusion and exclusion criteria will be included. Approximately 6 interventional cardiologists, 2 diagnostic cardiologists and 10 fellows will be included in this study.

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 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Operators: Interventional or diagnostic interventional attendings and fellows, operators willing to participate.
  • Patients: Age 18-89 years old requiring catheterization at Geisinger Medical Center using radial access

排除标准

  • patients with CABG, requiring extensive imaging, with operator switch during the procedure
  • patients in whom the procedure took unusual time because of anatomic issues, and need to switch to alternative access.

研究组 & 干预措施

Board (Rad Board")

Experimental

Radial artery catheterization is performed using radio-opaque armboard

干预措施: Board (Device)

No Board

Active Comparator

Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield

干预措施: No Board (Device)

结局指标

主要结局

Operator Radiation Exposure

时间窗: during initial diagnostic catheterization procedure, an average of 30 minutes

mSieverts radiation dose to the operator during diagnostic catheterization

次要结局

  • Radiation Exposure to Operator During Diagnostic Catheterization With Versus Without Ventriculography/Aortography(During procedure, an average of 35 minutes)

研究者

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

James C. Blankenship

Director of Cardiology

Geisinger Clinic

研究点 (2)

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