Individual Dosimetric Monitoring of Workers During Interventional Radiology and Cardiology Procedures for Cardiologists and Radiologists in France
- Conditions
- Radiation Exposure
- Interventions
- Other: Dosimetric monitoring
- Registration Number
- NCT05561439
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Radiology: Mixed Dosimetric monitoring - Cardiology: Rhythmology Dosimetric monitoring - Cardiology: Coronary/Valvular Dosimetric monitoring - Cardiology: Mixed Dosimetric monitoring - Radiology: Complex Vascular Dosimetric monitoring - Radiology: Mixed Vascular Dosimetric monitoring - Radiology: Complex Osteoarticular Dosimetric monitoring - Radiology: Simple Osteoarticular Dosimetric monitoring - Radiology: Complex Neuroradiology Dosimetric monitoring - Radiology: Mixed Neuroradiology Dosimetric monitoring - Radiology: Complex Oncology Dosimetric monitoring - Radiology: Simple Neuroradiology Dosimetric monitoring - Radiology: Simple Vascular Dosimetric monitoring - Radiology: Mixed Osteoarticular Dosimetric monitoring - Radiology: Simple Oncology Dosimetric monitoring - Radiology: Mixed Oncology Dosimetric monitoring -
- Primary Outcome Measures
Name Time Method Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed 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 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 2021 mSv
- Secondary Outcome Measures
Name Time Method Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed 2021 Yes/no; classed as used systematically (100% of the time), often (\> 50% of the time), infrequently (\<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Availability and frequency of use for each passive dosimeter 2021 Yes/no for each passive dosimeter (whole body, extremities, lens) 4 categories: worn systematically (100% of the time), often (\> 50% of the time), infrequently (\<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed 2021 Yes/no; classed as used systematically (100% of the time), often (\> 50% of the time), infrequently (\<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
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 Yes/no; classed as used systematically (100% of the time), often (\> 50% of the time), infrequently (\<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed 2021 Yes/no; classed as used systematically (100% of the time), often (\> 50% of the time), infrequently (\<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
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 Gy.cm²
High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed 2021 Yes/no; classed as used systematically (100% of the time), often (\> 50% of the time), infrequently (\<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed 2021 Yes/no; classed as used systematically (100% of the time), often (\> 50% of the time), infrequently (\<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Physician exposure according to total number of procedures 2021 mSv: Information taken from Dosimetry Archiving and Communication System
Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed 2021 Yes/no; classed as used systematically (100% of the time), often (\> 50% of the time), infrequently (\<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Gloves use by interventional physicians according to specialty, activity and type of procedures performed 2021 Yes/no; classed as used systematically (100% of the time), often (\> 50% of the time), infrequently (\<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Physician exposure according to number of procedures by type of specialty 2021 mSv: Information taken from Dosimetry Archiving and Communication System
Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed 2021 Yes/no; classed as used systematically (100% of the time), often (\> 50% of the time), infrequently (\<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Patient radiation protection training status according to specialty, activity and type of procedures performed 2021 Up-to-date/needs renewing/never completed
Worker radiation protection training status according to specialty, activity and type of procedures performed 2021 Up-to-date/needs renewing/never completed
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 mGy
Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed 2020 Yes/no; classed as used systematically (100% of the time), often (\> 50% of the time), infrequently (\<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed 2021 Yes/no; classed as used systematically (100% of the time), often (\> 50% of the time), infrequently (\<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Physician exposure according to number of procedures by modality 2021 mSv: Information taken from Dosimetry Archiving and Communication System
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 mGy.cm
Trial Locations
- Locations (1)
CHU de Nîmes
🇫🇷Nîmes, France