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

Radiation Exposure Clinical Trial

— DOSE RPW-CRI  

Official title:

Multicenter Retrospective Study of Passive Dosimeter Results for Interventional Cardiologists and Radiologists

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05561439
• Other study ID #: NIMAO/2021-01 /CD-01
• Status: Recruiting
• Start date: September 2, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Cyril Duverger
• Phone: 04.66.68.42.27
• Email: cyril.duverger[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Radiation Exposure

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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,
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient radiation protection training status according to specialty, activity and type of procedures performed	Up-to-date/needs renewing/never completed	2019,
Secondary	Patient radiation protection training status according to specialty, activity and type of procedures performed	Up-to-date/needs renewing/never completed	2020
Secondary	Patient radiation protection training status according to specialty, activity and type of procedures performed	Up-to-date/needs renewing/never completed	2021
Secondary	Worker radiation protection training status according to specialty, activity and type of procedures performed	Up-to-date/needs renewing/never completed	2019
Secondary	Worker radiation protection training status according to specialty, activity and type of procedures performed	Up-to-date/needs renewing/never completed	2020
Secondary	Worker radiation protection training status according to specialty, activity and type of procedures performed	Up-to-date/needs renewing/never completed	2021
Secondary	Physician exposure according to total number of procedures	mSv: Information taken from Dosimetry Archiving and Communication System	2019
Secondary	Physician exposure according to total number of procedures	mSv: Information taken from Dosimetry Archiving and Communication System	2020
Secondary	Physician exposure according to total number of procedures	mSv: Information taken from Dosimetry Archiving and Communication System	2021
Secondary	Physician exposure according to number of procedures by type of specialty	mSv: Information taken from Dosimetry Archiving and Communication System	2019
Secondary	Physician exposure according to number of procedures by type of specialty	mSv: Information taken from Dosimetry Archiving and Communication System	2020
Secondary	Physician exposure according to number of procedures by type of specialty	mSv: Information taken from Dosimetry Archiving and Communication System	2021
Secondary	Physician exposure according to number of procedures by modality	mSv: Information taken from Dosimetry Archiving and Communication System	2219
Secondary	Physician exposure according to number of procedures by modality	mSv: Information taken from Dosimetry Archiving and Communication System	2020
Secondary	Physician exposure according to number of procedures by modality	mSv: Information taken from Dosimetry Archiving and Communication System	2021
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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