Reference Dose Levels During Fluoroscopically Guided Procedures in Operating Rooms

Summary

This study is conducted by a working group of the French Society of Medical Physics (SFPM). Its main aim is to establish reference dose levels for the most common procedures performed in operating rooms using mobile X-ray systems, hence helping medical physicists and surgeons to evaluate their practice and optimize patient radiation protection.

This is a multi-centric prospective study involving 73 medical institutions of different categories (public university hospitals, clinics, centers dedicated to cancer treatment, etc.). It consists on progressively collecting anonymous data for 15 to 30 procedures from a list of 62 types of procedures, belonging to 7 surgery specialties (neurosurgery, orthopedic surgery, digestive surgery, urology, cardiology, vascular surgery and multi-specialty). Collected data include patient BMI and information about the X-ray equipment, the medical procedure and the dosimetric parameters. Data collection doesn't require the access to the patient medical record and doesn't impact his medical care.

Proposed dose reference levels will be expressed in terms of KAP (Kerma-Area-Product), fluoroscopy time and air Kerma. Moreover, multiple statistical analyses will be done to investigate the impact of different variables on the procedure X-ray doses.

Conditions

• Radiation Exposure

Sponsors & Collaborators

• Hopital Lariboisière

  collaborator OTHER

• University hospital, Angers, FRANCE

  collaborator UNKNOWN

• University hospital of Montpellier, FRANCE

  collaborator UNKNOWN

• Fréjus-Saint-Raphaël hospital, FRANCE

  collaborator UNKNOWN

• C2i Santé, FRANCE

  collaborator UNKNOWN

• Societe Francaise de Physique Medicale

  lead OTHER

Principal Investigators

• Djamel DABLI, PhD · University hospital of Nîmes, France

• Brice ROYER, MS · C2i Santé, FRANCE

• Mathilde DEMONCHY, PhD · Fréjus-Saint-Raphaël hospital, FRANCE

• Julien LE ROY, PhD · University hospital of Montpellier, FRANCE

Eligibility

Min Age

16 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-03

Primary Completion

2019-03-30

Completion

2019-08-30

Countries

• France

Study Locations