Reference Dose Levels During Fluoroscopically Guided Procedures in Operating Rooms
Condition: Radiation Exposure
Study type: Observational [Patient Registry]

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.
    

Detailed description: 
      Context:

      Reference dose levels, introduced by the International Commission on Radiological Protection
      (ICRP) in 1996, are intended to help professionals using medical imaging to evaluate their
      practice and optimize patient's doses. European directive 2013/59/Euratom emphasizes the need
      to establish, use and regularly review reference levels for diagnostic and interventional
      procedures and to publish guidelines on this topic. Furthermore, national reference levels
      were established for conventional radiology and CT exams. They are used as a tool for the
      optimization of medical practices. Besides, a working group of the French Society of Medical
      Physics (SFPM) has published in 2017 reference levels for interventional radiology procedures
      performed in a dedicated room and using fixed angiographic equipment. Although radiation
      protection is a big challenge encountered in operating rooms using mobile X-ray equipment,
      few data are available in the literature regarding the use of this type of equipment.

      In this context, the SFPM suggested the creation of a working group in 2017 to establish
      reference levels for the main procedures realized in the operating rooms using mobile X-ray
      systems. The aim of this working group is to help medical physicists and surgeons in
      evaluating their practice and optimizing patient radiation protection.

      Scope of the study: The main purpose of the study is to establish dosimetric reference
      levels, in terms of KAP (Kerma-Area-Product). Additional objectives consist on proposing
      reference levels in terms of fluoroscopy time and air kerma and on studying the impact of
      different parameters (surgical specialty, body mass index, use of zoom, fluoroscopy pulse
      rate) on the delivered doses.

      Study type and cohort: This is a multi-centric prospective study which consists on
      progressively collecting anonymous data for 15 to 30 procedures from a list of 62 surgical
      procedures (n=62) belonging to 7 different surgery specialties. Selected specialties are
      neurosurgery (n=12), orthopedic surgery (n=15), digestive surgery (n=6), urology (n=10),
      cardiology (n=6), vascular surgery (n=11), multi-specialty (n=2). 73 health institutions of
      different categories (University hospitals, clinics, centers dedicated to cancer treatment,
      etc..) confirmed their participations to the study.

      Data collection: Data will be collected using a password-protected Excel spreadsheet. This
      excel file will be sent to all the participating institutions at the beginning of data
      collection. Every institution will send the excel file completed with anonymized data to the
      scientific responsible of the study through the secure email server of the APHP (Assistance
      Publique des Hopitaux de Paris)) institution.

      Analysis: The main goal of this study is to publish descriptive statistics parameters (mean,
      standard deviation, median, 1st quartile, 3rd quartile) for each dosimetric data (KAP,
      fluoroscopy time, kerma, etc..) and for each category of surgical procedures. Results will be
      presented with a 95 percentage confidence interval.

      Moreover, correlation analysis between several variables will be done. The differences
      between detector and equipment technologies will be also studied using appropriate
      statistical tests.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population consists on unhealthy patients undergoing surgical procedures with the use
        of X-ray mobile equipement. 62 types of procedures, belonging to 7 surgery specialties
        (neurosurgery, orthopedic, digestive, urology, cardiology, vascular and multi-specialty)
        are included in this study. For each procedure and each participating institution among the
        73 centers that have sent their participation agreement, 15 to 30 procedures will be
        collected and analysed.
      
Keywords: Reference dose levels; Surgery; C-arm; Orthopedic; Urology; Vascular; Neurosurgery; Cardiology; Digestive; Fluoroscopy; Patient radiation protection; X-ray; Interventional radiology; Optimization; Kerma Area Product