Clinical trial NCT05561439: Individual Dosimetric Monitoring of Workers During Interventional Radiology and Cardiology Procedures for Cardiologists and Radiologists in France
Official title: Multicenter Retrospective Study of Passive Dosimeter Results for Interventional Cardiologists and Radiologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Exposure
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
timeFrame: 2019
measure: Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
timeFrame: 2020
measure: Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
timeFrame: 2021
measure: 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
timeFrame: 2019
measure: 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
timeFrame: 2020
measure: 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
timeFrame: 2021
measure: 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
timeFrame: 2019
measure: 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
timeFrame: 2020
measure: 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
timeFrame: 2021
Secondary outcomes:
measure: Availability and frequency of use for each passive dosimeter
timeFrame: 2019
measure: Availability and frequency of use for each passive dosimeter
timeFrame: 2020
measure: Availability and frequency of use for each passive dosimeter
timeFrame: 2021
measure: High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2019
measure: High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2020
measure: High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2021
measure: High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2019
measure: High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2020
measure: High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2021
measure: Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2019
measure: Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2020
measure: Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2021
measure: Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2019
measure: Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2020
measure: Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2021
measure: Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2019
measure: Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2020
measure: Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2021
measure: Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2019
measure: Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2020
measure: Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2021
measure: Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2019
measure: Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2020
measure: Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2021
measure: Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2019,
measure: Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2020
measure: Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2021
measure: Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2019, 2020 and 2021
measure: Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2019
measure: Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2020
measure: Gloves use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2021
measure: Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2019
measure: Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2020
measure: Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed
timeFrame: 2021
measure: Patient radiation protection training status according to specialty, activity and type of procedures performed
timeFrame: 2019,
measure: Patient radiation protection training status according to specialty, activity and type of procedures performed
timeFrame: 2020
measure: Patient radiation protection training status according to specialty, activity and type of procedures performed
timeFrame: 2021
measure: Worker radiation protection training status according to specialty, activity and type of procedures performed
timeFrame: 2019
measure: Worker radiation protection training status according to specialty, activity and type of procedures performed
timeFrame: 2020
measure: Worker radiation protection training status according to specialty, activity and type of procedures performed
timeFrame: 2021
measure: Physician exposure according to total number of procedures
timeFrame: 2019
measure: Physician exposure according to total number of procedures
timeFrame: 2020
measure: Physician exposure according to total number of procedures
timeFrame: 2021
measure: Physician exposure according to number of procedures by type of specialty
timeFrame: 2019
measure: Physician exposure according to number of procedures by type of specialty
timeFrame: 2020
measure: Physician exposure according to number of procedures by type of specialty
timeFrame: 2021
measure: Physician exposure according to number of procedures by modality
timeFrame: 2219
measure: Physician exposure according to number of procedures by modality
timeFrame: 2020
measure: Physician exposure according to number of procedures by modality
timeFrame: 2021
measure: 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
timeFrame: 2019
measure: 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
timeFrame: 2020
measure: 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
timeFrame: 2021
measure: 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
timeFrame: 2019
measure: 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
timeFrame: 2020
measure: 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
timeFrame: 2021
measure: 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
timeFrame: 2019
measure: 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
timeFrame: 2020
measure: 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
timeFrame: 2021
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU de Nimes
name: Cyril Duverger
role: PRINCIPAL_INVESTIGATOR
References: