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

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.

Study Overview

• Status: Completed
• Conditions: Radiation Exposure
• Intervention / Treatment: Other: Dosimetric monitoring

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHU de Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants in the study will be interventional cardiologists and interventional radiologists exposed to radiation during their interventional procedures performed as part of their activity.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Retrospective

Number of groups / cohorts

16

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiology: Coronary/Valvular	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Cardiology: Rhythmology	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Cardiology: Mixed	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Radiology: Simple Vascular	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Radiology: Complex Vascular	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Radiology: Mixed Vascular	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Radiology: Simple Osteoarticular	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Radiology: Complex Osteoarticular	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Radiology: Mixed Osteoarticular	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Radiology: Simple Neuroradiology	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Radiology: Complex Neuroradiology	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Radiology: Mixed Neuroradiology	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Radiology: Mixed	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Radiology: Simple Oncology	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Radiology: Complex Oncology	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
Radiology: Mixed Oncology	Other: Dosimetric monitoring; Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Availability and frequency of use for each passive dosimeter	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	2019
Availability and frequency of use for each passive dosimeter	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	2020
Availability and frequency of use for each passive dosimeter	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	2021
High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2019
High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2020
High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2021
High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2019
High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2020
High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2021
Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2019
Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2020
Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2021
Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2019
Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2020
Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	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	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	2019
Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2020
Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2021
Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2019
Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2020
Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2021
Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2019
Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2020
Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2021
Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2019,
Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2020
Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2021
Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2019, 2020 and 2021
Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2019
Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2020
Gloves use by interventional physicians according to specialty, activity and type of procedures performed	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	2021
Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2019
Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2020
Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed	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	2021
Patient radiation protection training status according to specialty, activity and type of procedures performed	Up-to-date/needs renewing/never completed	2019,
Patient radiation protection training status according to specialty, activity and type of procedures performed	Up-to-date/needs renewing/never completed	2020
Patient radiation protection training status according to specialty, activity and type of procedures performed	Up-to-date/needs renewing/never completed	2021
Worker radiation protection training status according to specialty, activity and type of procedures performed	Up-to-date/needs renewing/never completed	2019
Worker radiation protection training status according to specialty, activity and type of procedures performed	Up-to-date/needs renewing/never completed	2020
Worker radiation protection training status according to specialty, activity and type of procedures performed	Up-to-date/needs renewing/never completed	2021
Physician exposure according to total number of procedures	mSv: Information taken from Dosimetry Archiving and Communication System	2019
Physician exposure according to total number of procedures	mSv: Information taken from Dosimetry Archiving and Communication System	2020
Physician exposure according to total number of procedures	mSv: Information taken from Dosimetry Archiving and Communication System	2021
Physician exposure according to number of procedures by type of specialty	mSv: Information taken from Dosimetry Archiving and Communication System	2019
Physician exposure according to number of procedures by type of specialty	mSv: Information taken from Dosimetry Archiving and Communication System	2020
Physician exposure according to number of procedures by type of specialty	mSv: Information taken from Dosimetry Archiving and Communication System	2021
Physician exposure according to number of procedures by modality	mSv: Information taken from Dosimetry Archiving and Communication System	2219
Physician exposure according to number of procedures by modality	mSv: Information taken from Dosimetry Archiving and Communication System	2020
Physician exposure according to number of procedures by modality	mSv: Information taken from Dosimetry Archiving and Communication System	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	Gy.cm²	2019
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	Gy.cm²	2020
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	Gy.cm²	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	mGy	2019
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	mGy	2020
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	mGy	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	mGy.cm	2019
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	mGy.cm	2020
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	mGy.cm	2021

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Cyril Duverger, CHU de Nimes

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NIMAO/2021-01 /CD-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No