RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields (The RADIATION Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 452
- 试验地点
- 1
- 主要终点
- Radiation dose adsorbed by operators
研究概览
简要总结
During percutaneous coronary interventions standard operator radio-protection is generally ensured using a lead apron, a thyroid lead collar, low leaded flaps, an upper mobile leaded glass suspended from the ceiling and leaded glasses. Previous studies showed that adding a bismuth-barium radiation shield drape on the patient right arm or using a pelvic lead shield on the patient, the radiation dose adsorbed by operators was significantly reduced even if was higher compared to transfemoral approach. No studies evaluated the effect of both adjunctive shields placed in the same patient.
Aim of our randomized study is to evaluate if the combination of a shield drape on the patient right arm and a pelvic lead shield during transradial percutaneous coronary procedures may reduce the radiation dose adsorbed by operators compared to the use of only one shield or none.
All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study. Eligible patients will be randomized (using a computer generated randomization sequence) in 4 groups:
- use of a pelvic shield drape
- use of a shield drape on the patient right arm
- use of a pelvic shield drape and a shield drape on the patient right arm
- Any adjunctive shield drape (only standard radio-protection) For each group a further internal randomization will be performed in order to compare the right or left radial transradial approach.
Each operator will be equipped with dedicated dosimeters placed at left wrist and at thorax level outside the lead apron. Since December 2013 the operators are equipped with a further dosimeter at head level.
Primary end-point of the study is the radiation dose adsorbed at wrist and thorax by operators and detected by the electronic dosimeters.
Secondary end-point are:
- Radiation dose adsorbed by operators according to the radial access (right versus left)
- Radiation dose adsorbed by the patients
- Radiation dose adsorbed at head level.
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
- 否
入选标准
- •All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study
排除标准
- •Previous coronary artery by-pass
- •Acute ST elevation myocardial infarction
- •Hemodynamic instability or cardiogenic shock
- •Ischemic Allen test.
结局指标
主要结局
Radiation dose adsorbed by operators
时间窗: During procedure
Primary end-point of the study is the radiation dose adsorbed at wrist and thorax by operators and detected by the electronic dosimeters
次要结局
- Radiation dose adsorbed by operators according to the radial access (right versus left)(During procedure)
- Radiation dose adsorbed by the patients(During procedure)
研究者
Alessandro Sciahbasi, MD
Interventional Cardiologist
Ospedale Sandro Pertini, Roma