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

Completed
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
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Radiology: MixedDosimetric monitoring-
Cardiology: RhythmologyDosimetric monitoring-
Cardiology: Coronary/ValvularDosimetric monitoring-
Cardiology: MixedDosimetric monitoring-
Radiology: Complex VascularDosimetric monitoring-
Radiology: Mixed VascularDosimetric monitoring-
Radiology: Complex OsteoarticularDosimetric monitoring-
Radiology: Simple OsteoarticularDosimetric monitoring-
Radiology: Complex NeuroradiologyDosimetric monitoring-
Radiology: Mixed NeuroradiologyDosimetric monitoring-
Radiology: Complex OncologyDosimetric monitoring-
Radiology: Simple NeuroradiologyDosimetric monitoring-
Radiology: Simple VascularDosimetric monitoring-
Radiology: Mixed OsteoarticularDosimetric monitoring-
Radiology: Simple OncologyDosimetric monitoring-
Radiology: Mixed OncologyDosimetric monitoring-
Primary Outcome Measures
NameTimeMethod
Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed2021

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 performed2021

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 performed2021

mSv

Secondary Outcome Measures
NameTimeMethod
Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed2021

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 dosimeter2021

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 performed2021

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 performed2021

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 performed2021

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 performed2021

Gy.cm²

High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed2021

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 performed2021

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 procedures2021

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 performed2021

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 performed2021

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 specialty2021

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 performed2021

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 performed2021

Up-to-date/needs renewing/never completed

Worker radiation protection training status according to specialty, activity and type of procedures performed2021

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 performed2021

mGy

Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed2020

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 performed2021

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 modality2021

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 performed2021

mGy.cm

Trial Locations

Locations (1)

CHU de Nîmes

🇫🇷

Nîmes, France

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