Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06659939

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

X-Ray

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital, Orléans, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Badge-dosi

Device

The intervention assessed consists in linking the radiation dosimeter to the access badge (which practitioners wear at all times) in order to improve compliance with radiation dosimeter wear among practitioners exposed to X-rays.

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

    Time frame: 6 months

    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).

Secondary outcomes

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

    Time frame: Month 0, month 3 and month 6

    Passive dosimeter wearing rate is assessed at M0, M3 and M6 by a declarative questionnaire (TEST group).

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

    Time frame: Month 3 and month 6

    Difference in radiation measured in mSv between the BadgeDosi and the dosimeter alone (TEST group, M3 and M6).

  3. 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).

    Time frame: Month 3 and month 6

    Difference in radiation measured in mSv between the dosimeters of the TEST group and of the VIE control group (M3 and M6).

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

    Time frame: Month 3 and month 6

    Questionnaire on feedback (ergonomics, usability, satisfaction) from the TEST group and the VIE control group (M3 and M6).

  5. 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).

    Time frame: Month 3 and month 6

    Difference in radiation measured in mSv between healthcare center and staff's homes (HOME control group, M3 and M6).

  6. 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).

    Time frame: Month 3 and month 6.

    Questionnaire on feedback from the TEST group M3 and M6

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Method for bAdge-dosi Monitoring of X-ray Exposure Values in Operating Theatre Surgery: a Multicentre Randomised Trial

Acronym: MAVERIC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.