Individual Dosimetric Monitoring of Workers During Interventional Radiology and Cardiology Procedures for Cardiologists and Radiologists in France
DOSE RPW-CRI
Multicenter Retrospective Study of Passive Dosimeter Results for Interventional Cardiologists and Radiologists
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2022
CompletedFirst Submitted
Initial submission to the registry
September 27, 2022
CompletedFirst Posted
Study publicly available on registry
September 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 10, 2025
March 1, 2025
1.3 years
September 27, 2022
March 7, 2025
Conditions
Outcome Measures
Primary Outcomes (9)
Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
mSv
2019
Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
mSv
2020
Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
mSv
2021
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
mSv
2019
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
mSv
2020
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
mSv
2021
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
mSv
2019
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
mSv
2020
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
mSv
2021
Secondary Outcomes (58)
Availability and frequency of use for each passive dosimeter
2019
Availability and frequency of use for each passive dosimeter
2020
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
2019
High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed
2020
- +53 more secondary outcomes
Study Arms (16)
Cardiology: Coronary/Valvular
Cardiology: Rhythmology
Cardiology: Mixed
Radiology: Simple Vascular
Radiology: Complex Vascular
Radiology: Mixed Vascular
Radiology: Simple Osteoarticular
Radiology: Complex Osteoarticular
Radiology: Mixed Osteoarticular
Radiology: Simple Neuroradiology
Radiology: Complex Neuroradiology
Radiology: Mixed Neuroradiology
Radiology: Mixed
Radiology: Simple Oncology
Radiology: Complex Oncology
Radiology: Mixed Oncology
Interventions
Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Eligibility Criteria
Participants in the study will be interventional cardiologists and interventional radiologists exposed to radiation during their interventional procedures performed as part of their activity.
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nîmes
Nîmes, France
Study Officials
- PRINCIPAL INVESTIGATOR
Cyril Duverger
CHU de Nimes
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2022
First Posted
September 30, 2022
Study Start
September 2, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
March 10, 2025
Record last verified: 2025-03