Reference Dose Levels During Fluoroscopically Guided Procedures in Operating Rooms

Reference Dose Levels During Fluoroscopically Guided Procedures Performed Using Mobile X-ray Systems in Operating Rooms

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.

Study Overview

• Status: Completed
• Conditions: Radiation Exposure

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.

• Study Type: Observational
• Enrollment (Actual): 8840

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Hopital Lariboisiere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Year of construction of the equipment and date of the last external quality control (QC) (yyyy)	Year of construction of the equipment and date of the last external quality control	baseline
Image receptor type of the equipment	Participants should specify whether the images are obtained using a flat panel detector or an X-ray image intensifier.	baseline
DACS Connection	Participants should specify If the X-ray equipment is connected to a Dose Archiving and a Communication system (DACS) (Yes/no)	baseline
Patient weight (kg) and height (cm)	Weight and height will be combined to report BMI in kg/m^2.	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)	Size of the smallest and largest Field of View (FOV); size of the largest FOV adapted to the size of the phantom; size of the most used FOV for the concerned procedure. (cm)	Baseline, The most used FOV during the procedure is provided by the medical staff
Differences between the displayed and measured X-ray doses (percentage)	Differences between the displayed and measured KAP for the smallest and biggest FOV; Differences between the displayed and measured air kerma available in the last quality control (QC) report. (Percentages).	baseline
Total air kerma of the procedure including the one performed of an O-arm equipment	Participants should specify the unit by choosing the appropriate one among a list of 5 units (micro Gray, milli Gray, centi Gray, deci Gray, Gray).	Data are provided by the X-ray equipment at the end of the procedure
Total number of image frames (number)	Total number of image frames (number)	Data are provided by the X-ray equipment at the end of the procedure
Fluoroscopy mode used during the procedure	Participants should specify whether continuous, pulsed or mixed fluoroscopy modes are used during the procedure	Data are provided by the X-ray equipment at the end of the procedure
Fluoroscopy pulse rate ( pulses/second)		Data are provided by the X-ray equipment at the end of the procedure
Fluoroscopy time (hh:mm:ss) of the procedure including the one performed of an O-arm equipment		Data are provided by the X-ray equipment at the end of the procedure
KAP (Kerma-Area-Product) attributable to fluoroscopy	Participants should choose the appropriate unit of the KAP among a list of five units (µGy.m², mGy.cm², cGy.cm², dGy.cm², Gy.cm²).	Data are provided by the X-ray equipment at the end of the procedure
Medical specialty of the procedure	Participants should specify the medical specialty of the procedure by selecting one from a predefined list of seven categories: Orthopedic surgery, neurosurgery, cardiology, vascular surgery, urology, digestive surgery and multi-specialty.	Data are provided by the medical staff during the procedure
Name/type of the procedure	Participants should specify the medical description of the procedure.	Data are provided by the medical staff during the procedure
Additional information about the procedure giving further indications about the used materials or the anatomical region of interest.		Data are provided by the medical staff during the procedure
Total KAP for procedures performed on an O-arm equipment	Participants should choose the appropriate unit of the KAP among a list of five units (µGy.m², mGy.cm², cGy.cm², dGy.cm², Gy.cm²).	KAP is provided by the X-ray equipment at the end of the procedure
Total DLP (Dose-Length-Product) of the procedures performed on an O-arm equipment.DLP is always expressed in mGy.cm.	The DLP (Dose Length Product) is expressed in milliGray *centimeters (mGy.cm)	DLP is provided by the X-ray equipment at the end of the procedure
CTDIvol (Volume Computed Tomography Dose Index) of the procedures performed on an O-arm equipment. CTDI is always expressed in mGy.	The CTDIvol is a standardized measure of radiation dose output of a CT scanner. This dose is expressed in milliGrays (mGy).	CTDIvol is provided by the X-ray equipment at the end of the procedure
Type of the dosimetric phantom used to calculate the CTDI of an acquisition for the procedures performed on an O-arm equipment.	Participants should select between a "head phantom (16 cm)" or a "body phantom (32 cm)"	Data are provided by the X-ray equipment at the end of the procedure

Collaborators and Investigators

• Sponsor: Societe Francaise de Physique Medicale
• Collaborators: Hopital Lariboisière; University hospital, Angers, FRANCE; University hospital of Montpellier, FRANCE; Fréjus-Saint-Raphaël hospital, FRANCE; C2i Santé, FRANCE
• Investigators: Principal Investigator: Djamel DABLI, PhD, University Hospital of Nimes, 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2018
• Primary Completion (ACTUAL): March 30, 2019
• Study Completion (ACTUAL): August 30, 2019

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (ACTUAL): August 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Surgery; Neurosurgery; Optimization; Urology; Cardiology; X-ray; Vascular; Fluoroscopy; Interventional radiology; Orthopedic; Digestive; C-arm; Reference dose levels; Patient radiation protection; Kerma Area Product
• Other Study ID Numbers: gtsfpmnrbloc2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Only the final results of this study will be shared with the medical physicist members of the French Society of Medical Physicist. These results are statistical data analysis based on the collected patient data.

Moreover, the study main results would be probably shared with the scientific community through a published paper in a scientific peer-reviewed journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No