Individual Dosimetric Monitoring of Workers During Interventional Radiology and Cardiology Procedures for Cardiologists and Radiologists in France

NCT ID: NCT05561439

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-02

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Radiation Exposure

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cardiology: Coronary/Valvular

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Cardiology: Rhythmology

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Cardiology: Mixed

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Radiology: Simple Vascular

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Radiology: Complex Vascular

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Radiology: Mixed Vascular

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Radiology: Simple Osteoarticular

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Radiology: Complex Osteoarticular

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Radiology: Mixed Osteoarticular

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Radiology: Simple Neuroradiology

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Radiology: Complex Neuroradiology

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Radiology: Mixed Neuroradiology

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Radiology: Mixed

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Radiology: Simple Oncology

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Radiology: Complex Oncology

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Radiology: Mixed Oncology

Dosimetric monitoring

Intervention Type OTHER

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Interventions

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Dosimetric monitoring

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Intervention Type OTHER

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cyril Duverger

Role: PRINCIPAL_INVESTIGATOR

CHU de Nimes

Locations

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CHU de Nîmes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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NIMAO/2021-01 /CD-01

Identifier Type: -

Identifier Source: org_study_id

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