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

NCT ID: NCT06659939

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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X-Ray

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University hospital

Orléans, , France

Site Status RECRUITING

University hospital

Toulouse, , France

Site Status RECRUITING

University hospital

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Serge MAIA, Dr

Role: CONTACT

234389415 ext. +33

Facility Contacts

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Ivan N'GOU, Dr

Role: primary

238613027 ext. +33

Sébastien BALDUYCK, Dr

Role: primary

561777547 ext. +33

Serge MAIA, Dr

Role: primary

234389415 ext. +33

Other Identifiers

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DR240215 - MAVERIC

Identifier Type: -

Identifier Source: org_study_id

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