Evaluation of a New Device Placed Under the Angiographic Table to Reduce Operator Radiation Exposure During Percutaneous Coronary Procedures Through Transradial Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Operator pelvic dose
研究概览
简要总结
Radiation dose to interventional cardiologists performing transradial percutaneous coronary procedures is higher compared to those performing transfemoral exams. The radiation dose seems particularly high at pelvic level. We prepared an home-made protective extension of the leaded curtain under table that should reduce the operator exposure during interventional coronary procedures. The aim of the study is to evaluate the procedural efficacy of the protective extension on the operator radiation dose at pelvic level
详细描述
Interventional cardiologists are routinely exposed to x-rays during their activity increasing the risk of deterministic and stochastic effects. Consequently all the operators should be aware of the possible risks and they should apply all efforts to reduce the radiation dose according to the "As Low As Reasonably Achievable" (ALARA) principle. Moreover interventional cardiologists have to utilise adequate protection devices (lead apron, protective thyroid collar, lead glasses).
Operator performing transradial access procedures showed a significantly higher radiation exposure compared to those performing transfemoral interventions. So, transradial operators should use adjunctive protective shields (as leaded pelvic drapes placed on the patient abdomen) in order to reduce their radio-exposition.
During transradial access a particularly high radiation exposure is observed at operator pelvic level and the use of the protective adjunctive drapes placed on the patient abdomen is only partially effective to control this exposition.
Aim of our study was to evaluate the effect of a protective extension of the leaded curtain placed under the angiographic table in term of operator radiation exposure at pelvic level
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •all patient undergoing percutaneous coronary procedures through transradial access
排除标准
- •Interventions performed through a different vascular access
- •Procedures performed in patients with ST elevation acute myocardial infarction
- •Haemodynamic instability
- •Lack of written informed consent
- •Age < 18 years old
- •Previous coronary artery by-pass
研究组 & 干预措施
SCUT
Use of a "Small Curtain under table" (SCUT) placed under the cranial part of the angiographic table
干预措施: SCUT (Device)
Control
Control Group without the SCUT
结局指标
主要结局
Operator pelvic dose
时间窗: 24 hours
Operator radiation dose at pelvic level
次要结局
- Operator pelvic dose and experimental curtain utilized(24 hours)
- Operator thorax dose(24 hours)
- Operator head dose(24 hours)
研究者
Alessandro Sciahbasi, MD
MD, PhD
Ospedale Sandro Pertini, Roma