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Individual Dosimetric Monitoring of Workers During Interventional Radiology and Cardiology Procedures for Cardiologists and Radiologists in France (DOSE RPW-CRI)

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Radiation Exposure

Treatments

Other: Dosimetric monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT05561439
NIMAO/2021-01 /CD-01

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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)

Trial design

200 participants in 16 patient groups

Cardiology: Coronary/Valvular
Treatment:
Other: Dosimetric monitoring
Cardiology: Rhythmology
Treatment:
Other: Dosimetric monitoring
Cardiology: Mixed
Treatment:
Other: Dosimetric monitoring
Radiology: Simple Vascular
Treatment:
Other: Dosimetric monitoring
Radiology: Complex Vascular
Treatment:
Other: Dosimetric monitoring
Radiology: Mixed Vascular
Treatment:
Other: Dosimetric monitoring
Radiology: Simple Osteoarticular
Treatment:
Other: Dosimetric monitoring
Radiology: Complex Osteoarticular
Treatment:
Other: Dosimetric monitoring
Radiology: Mixed Osteoarticular
Treatment:
Other: Dosimetric monitoring
Radiology: Simple Neuroradiology
Treatment:
Other: Dosimetric monitoring
Radiology: Complex Neuroradiology
Treatment:
Other: Dosimetric monitoring
Radiology: Mixed Neuroradiology
Treatment:
Other: Dosimetric monitoring
Radiology: Mixed
Treatment:
Other: Dosimetric monitoring
Radiology: Simple Oncology
Treatment:
Other: Dosimetric monitoring
Radiology: Complex Oncology
Treatment:
Other: Dosimetric monitoring
Radiology: Mixed Oncology
Treatment:
Other: Dosimetric monitoring

Trial contacts and locations

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Central trial contact

Cyril Duverger

Data sourced from clinicaltrials.gov

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