Reference Dose Levels During Fluoroscopically Guided Procedures in Operating Rooms

Radiation Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03649451
• Other study ID #: gtsfpmnrbloc2017
• Status: Completed
• Start date: September 3, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: May 2020
• Source: Societe Francaise de Physique Medicale
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8840
• Est. completion date: August 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Radiation Exposure

Locations

Country	Name	City	State
France	Hopital Lariboisiere	Paris

Sponsors (6)

Lead Sponsor	Collaborator
Societe Francaise de Physique Medicale	C2i Santé, FRANCE, Fréjus-Saint-Raphaël hospital, FRANCE, Hopital Lariboisière, University hospital of Montpellier, FRANCE, University hospital, Angers, FRANCE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	DACS Connection	Participants should specify If the X-ray equipment is connected to a Dose Archiving and a Communication system (DACS) (Yes/no)	baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Fluoroscopy pulse rate ( pulses/second)		Data are provided by the X-ray equipment at the end of the procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	Name/type of the procedure	Participants should specify the medical description of the procedure.	Data are provided by the medical staff during the procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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