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

R

Regional University Hospital Center (CHRU)

Status

Enrolling

Conditions

X-Ray

Study type

Observational

Funder types

Other

Identifiers

NCT06659939
DR240215 - MAVERIC

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

240 participants in 3 patient groups

TEST group
Description:
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
Description:
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
Description:
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.

Trial contacts and locations

3

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Central trial contact

Serge MAIA, Dr

Data sourced from clinicaltrials.gov

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