Method for bAdge-dosi Monitoring of X-ray Exposure Values in Operating Theatre Surgery

NCT06659939 | Recruiting

• 1 other identifier: DR240215 - MAVERIC
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 3

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.

Conditions

X-Ray

Keywords

radioprotection; dosimeter; surgical staff; operating room; radiation monitoring; Badge

Outcome Measures

Primary Outcomes (1)

• 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

  Passive dosimeter wearing status (alone versus BadgeDosi) assessed once by an independent observer over the M6 period (during the sixth month of the study, TEST group).

  6 months

Secondary Outcomes (6)

• Evaluate the wearing rate the passive dosimeter assessed by questionnaire at M0, M3 and M6 (TEST group)

  Month 0, month 3 and month 6

• Study the evolution of radiation read on the BadgeDosi versus passive dosimeter alone among agents working in the operating room (TEST group).

  Month 3 and month 6

• 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).

  Month 3 and month 6

• Collect user feedback on the ergonomics the BadgeDosi (TEST and VIE groups).

  Month 3 and month 6

• 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).

  Month 3 and month 6

Study Arms (3)

TEST group

The TEST group's participants will be randomized in order to either wear the dosimeter alone (as usual) or the dosimeter associated with the access badge of the hospital "badge-dosi". The participants are working in the operating room and are exposed to X-rays

LIFE group

The LIFE group participants will wear a dosimeter associated with the access badge of the hospital "badge-dosi". The participants are working in the same hospital as the TEST group, but they are not exposed to any radiation at work.

HOME group

The HOME group participants will have a dosimeter alone which will be stored at home. The participants are working in the same hospital as the TEST group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

staff exposed to X-rays working in the operating room (TEST group)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (3)

University hospital

Orléans, 45000, France

RECRUITING

University hospital

Toulouse, 31000, France

RECRUITING

University hospital

Tours, 37044, France

RECRUITING

Central Study Contacts

Serge MAIA, Dr

CONTACT

234389415; S.maia@chu-tours.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: October 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

FR (3)