Clinical trial NCT06659939: Method for bAdge-dosi Monitoring of X-ray Exposure Values in Operating Theatre Surgery
Official title: Method for bAdge-dosi Monitoring of X-ray Exposure Values in Operating Theatre Surgery: a Multicentre Randomised Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: X-Ray
Keywords: radioprotection
dosimeter
surgical staff
operating room
radiation monitoring
Badge
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: staff exposed to X-rays working in the operating room (TEST group)

Brief summary: Surgical procedures involving X-rays in the operating room have increased in recent years, thereby increasing the exposure of operating room staff to ionizing radiation. An individual dosimeter makes it possible to record the radiation exposure to which these personnel are exposed. However, it has been noticed that these dosimeters are not thoroughly worn, consequently the radiation doses recorded are not reliable.

In order to increase the proportion of dosimeters systematically worn in the operating room, we study the impact of the association of the passive dosimeter with the hospital access badge (forming the Badge-Dosi). A first pilot study was carried out at Tours University Hospital showing the effectiveness of this concept. With the present study, we carry out a multicenter study. Our hypothesis is that the Badge-Dosi allows a significant increase of dosimeter use in the operating room, which improves the reliability of the monitoring of personnel.


Eligibility criteria: Inclusion Criteria:

TEST group :

* People working in the operating room at least 80% of the time (excluding people working less than 80% of the time).
* Have been monitored by a delayed-reading dosimeter for at least 1 year.
* Carry an access card (i.e. be the holder).

LIFE group :

* Person working in the same centre as the people in the TEST group.
* Person not exposed to radiation at their workstation
* Holder of an access card

HOME group :

- Person working in the same centre as people in the TEST Group and live near the center

Exclusion Criteria:

For all Groups :

* Person objecting to data processing
* Interns/externs/non-permanent staff likely to change jobs during the study period
* Person who had a nuclear medicine examination within 15 days before the start of the study
* Anyone who had internal vectorised therapy with iodine-131 or Lu-177 within 30 days before the start of the study.

Primary outcomes:
measure: Improve the wearing of dosimeters by staff exposed to X-rays and working in the operating room thanks to the BadgeDosi solution in order to make the exposure measurements taken more reliable and interpretable compared to the passive dosimeter alone. (TES
timeFrame: 6 months
Secondary outcomes:
measure: Evaluate the wearing rate the passive dosimeter assessed by questionnaire at M0, M3 and M6 (TEST group)
timeFrame: Month 0, month 3 and month 6
measure: Study the evolution of radiation read on the BadgeDosi versus passive dosimeter alone among agents working in the operating room (TEST group).
timeFrame: Month 3 and month 6
measure: Study the variations of doses of a control group wearing the BadgeDosi but not exposed to ionizing radiation as part of their activity in the hospital (VIE group).
timeFrame: Month 3 and month 6
measure: Collect user feedback on the ergonomics the BadgeDosi (TEST and VIE groups).
timeFrame: Month 3 and month 6
measure: Monitor natural radioactivity between the healthcare center and the staff's homes. Special care is taken so the distribution of the places of residence of the staff around the hospital is represented (HOME group).
timeFrame: Month 3 and month 6
measure: Collect user feedback on the use of the UV box placed in the changing rooms for disinfection of personal objects (including but not limited to the BadgeDosi) entering the OR department (TEST groups).
timeFrame: Month 3 and month 6.
Other outcomes:
Locations:
city: Orleans
country: France
facility: University hospital
city: Toulouse
country: France
facility: University hospital
city: Tours
country: France
facility: University hospital
Study officials:
References: