Reference Dose Levels During Fluoroscopically Guided Procedures in Operating Rooms

NCT03649451 | Completed

• 1 other identifier: gtsfpmnrbloc2017
• Study Type: observational
• Target: 8,840
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Total KAP (Kerma-Air-Product)

  KAP or Kerma-Area-Product is the main dosimetric parameter representing the patient exposure. Participants should choose the appropriate unit of the KAP among a list of five units (microGray.m², milliGray.centimeter², centiGray.centimeter², deciGray.centimeter², Gray.centimeter²). Note that Gray is the international unit of the radiation quantity.

  KAP is provided by the X-ray equipment at the end of the procedure.

Secondary Outcomes (19)

• Year of construction of the equipment and date of the last external quality control (QC) (yyyy)

  baseline

• Image receptor type of the equipment

  baseline

• DACS Connection

  baseline

• Patient weight (kg) and height (cm)

  Patient weight and height are provided from the equipment or given by the medical team during the procedure

• Size of Fields of View (FOV) (cm)

  Baseline, The most used FOV during the procedure is provided by the medical staff

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Fluoroscopy guided procedures performed on adult patients (≥16 years old)
• Fluoroscopy guided procedures performed with mobile X-ray systems. Procedures performed outside of the operating rooms but using mobile X-ray systems are included in this study.
• Fluoroscopy guided procedures performed using mini C-arms or O-arms

You may not qualify if:

• Fluoroscopy guided procedures performed on pediatric patients (\<16 years old)
• Fluoroscopy guided procedures performed with a fixed interventional radiology imaging system even if it was located in the operating rooms .
• Medical procedures performed using both a mobile X-ray system and a fixed CT scanner.
• Medical procedures performed using a mobile intra-operative CT scanner

Sponsors & Collaborators

• Societe Francaise de Physique Medicale: lead
• Hopital Lariboisière: collaborator
• University hospital, Angers, FRANCE: collaborator
• University hospital of Montpellier, FRANCE: collaborator
• Fréjus-Saint-Raphaël hospital, FRANCE: collaborator
• C2i Santé, FRANCE: collaborator

Study Sites (1)

Hopital Lariboisiere

Paris, 75010, France

Location

Study Officials

• Djamel DABLI, PhD

  University hospital of Nîmes, France

  PRINCIPAL INVESTIGATOR

• Brice ROYER, MS

  C2i Santé, FRANCE

  PRINCIPAL INVESTIGATOR

• Mathilde DEMONCHY, PhD

  Fréjus-Saint-Raphaël hospital, FRANCE

  PRINCIPAL INVESTIGATOR

• Julien LE ROY, PhD

  University hospital of Montpellier, FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 28, 2018
• Study Start: September 3, 2018
• Primary Completion: March 30, 2019
• Study Completion: August 30, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)