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临床试验/NCT05561439
NCT05561439已完成不适用

Multicenter Retrospective Study of Passive Dosimeter Results for Interventional Cardiologists and Radiologists

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed

研究概览

简要总结

The objective of this study is to review the results of annual radiation doses received by interventional cardiologists and radiologists in France. The results of this study will allow the improvement of classification of interventional cardiology and radiology activities and procedures to help define radiation dose constraints for occupational exposure, according to the number and types of procedures performed.

The study is based on the hypothesis that some specialties in interventional cardiology (cardiology or rythmology procedures) and in interventional radiology (vascular, neuroradiology, osteoarticular) and some types of procedures present greater exposure risks for interventional cardiologists and radiologists. It is expected that the annual radiation dose limits for workers can be exceeded if good practices for both patient and worker radiation protection are not applied. Also, dosimetry equipment used to detect radiation dose although provided to the workers are not systematically worn by the physician during the procedure . The study is likely to show that for an equivalent speciality and number of procedures per type of act, the correct use of collective and personal radiation protection equipment (préciser) will lower occupational radiation exposure of physician . Similarly, for an equivalent activity and number of procedures per type of act , a trained physician would have a lower occupational exposure than an untrained physician. The physician's radiation exposure should therefore increase with a greater number of procedures per type of procedure performed and as the radiation dose delivered to the patient increase. Finally, there would be a different correlation between patient's radiation dose and physician's exposure depending on specialty, procedures, modality, experience and availability and use of collective and personal radiation protection equipment.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Physician performing interventional cardiology or radiology procedures with a fixed C-arm system
  • Physician systematically wearing at least one of the following personal dosimeters: whole body, extremities, lens.

排除标准

  • Physician who did not perform an interventional procedure during the observation period (2019-2021)
  • For the primary endpoint by year, physician with more than 3 months of missing data (more than one 3-month period or more than 3 1-month periods)

结局指标

主要结局

Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed

时间窗: 2021

mSv

Annual occupational radiation exposure levels for equivalent doses to the lens of the eye for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed

时间窗: 2021

mSv

Annual occupational radiation exposure levels for equivalent doses to the skin for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed

时间窗: 2021

mSv

次要结局

  • Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed(2021)
  • Availability and frequency of use for each passive dosimeter(2021)
  • High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed(2021)
  • Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed(2021)
  • Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed(2021)
  • Relationships between the whole body, extremity and lens radiation exposures and the Dose Area Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed(2021)
  • High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed(2021)
  • Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed(2021)
  • Physician exposure according to total number of procedures(2021)
  • Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed(2021)
  • Gloves use by interventional physicians according to specialty, activity and type of procedures performed(2021)
  • Physician exposure according to number of procedures by type of specialty(2021)
  • Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed(2021)
  • Patient radiation protection training status according to specialty, activity and type of procedures performed(2021)
  • Worker radiation protection training status according to specialty, activity and type of procedures performed(2021)
  • Relationships between whole body, extremity and lens exposures and the Air Kerma at the interventional reference point patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed(2021)
  • Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed(2020)
  • Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed(2021)
  • Physician exposure according to number of procedures by modality(2021)
  • Relationships between the physician's whole body, extremity and lens exposures and the Dose Length Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed(2021)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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