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临床试验/NCT02972736
NCT02972736已完成不适用

RadiatiOn Dose Among Different EndOvascular Procedures: the RODEO Study

Ospedale Sandro Pertini, Roma0 个研究点目标入组 17,711 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17,711
主要终点
Radiation dose expressed as DAP

研究概览

简要总结

Retrospective multicenter study aimed to evaluate radiation exposure associated with different interventional procedures involving interventional cardiologists, interventional radiologists and electrophysiologists.

详细描述

The use fluoroscopically guided interventional procedures is progressively increasing over the past 20 years.Some previous reports have shown that the radiation dose absorbed by interventional cardiologists is the greatest registered by any medical staff exposed to X-rays. However in recent years new procedures have been introduced and validated in the setting of interventional cardiology and radiology and there is wide variation in patient dose among different procedures.

Radiation issue is an important issue for patients and operators due to the acute deterministic effects and most important for the long term stochastic risk of cancer induction: however this problem is often under-evaluated. Even if the stochastic risk is an all-or-none phenomenon for any individual cell, the greater the radiation exposure, the more cells are injured. Moreover non cancerous effects are possible such as cataract formation in the eye and the probability increases with increasing dose.

Radiation dose can be expressed in different ways: the Air Kerma is the amount of energy absorbed in a given mass of air, whereas the Dose Area Product (DAP) is the absorbed dose of radiation across a given surface area. Generally DAP measurements are more accurate than using Air Kerma measurements for the estimation of patient radiation dose as DAP allows for variations in field size. DAP consents a good estimation of the dose to the irradiated tissue and is an indicator for patient cancer risk.

Aim of our study is to evaluate the radiation dose exposure during different fluoroscopically guided interventional procedures comparing different specialties (electrophysiology, interventional radiology, interventional cardiology).

Methods From January 2013 to December 2015 all diagnostic or interventional procedures performed by interventional operators will be included in this multicenter study without exclusion criteria.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All procedures for which DAP values are available

排除标准

  • Procedures without DAP

结局指标

主要结局

Radiation dose expressed as DAP

时间窗: 24 hours

次要结局

未报告次要终点

研究者

发起方
Ospedale Sandro Pertini, Roma
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandro Sciahbasi, MD

MD, PhD

Ospedale Sandro Pertini, Roma

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