Reduction in Physician Radiation Exposure During Radial Access Cardiac Catheterization Using a Radiation Protection Board
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
- 否
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")
Radial artery catheterization is performed using radio-opaque armboard
干预措施: Board (Device)
No Board
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
James C. Blankenship
Director of Cardiology
Geisinger Clinic
