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Reference Dose Levels During Fluoroscopically Guided Procedures in Operating Rooms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649451
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : May 13, 2020
Sponsor:
Collaborators:
Hopital Lariboisière
University hospital, Angers, FRANCE
University hospital of Montpellier, FRANCE
Fréjus-Saint-Raphaël hospital, FRANCE
C2i Santé, FRANCE
Information provided by (Responsible Party):
Societe Francaise de Physique Medicale

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.


Condition or disease
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 8840 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Reference Dose Levels During Fluoroscopically Guided Procedures Performed Using Mobile X-ray Systems in Operating Rooms
Actual Study Start Date : September 3, 2018
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays




Primary Outcome Measures :
  1. Total KAP (Kerma-Air-Product) [ Time Frame: KAP is provided by the X-ray equipment at the end of the procedure. ]
    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.


Secondary Outcome Measures :
  1. Year of construction of the equipment and date of the last external quality control (QC) (yyyy) [ Time Frame: baseline ]
    Year of construction of the equipment and date of the last external quality control

  2. Image receptor type of the equipment [ Time Frame: baseline ]
    Participants should specify whether the images are obtained using a flat panel detector or an X-ray image intensifier.

  3. DACS Connection [ Time Frame: baseline ]
    Participants should specify If the X-ray equipment is connected to a Dose Archiving and a Communication system (DACS) (Yes/no)

  4. Patient weight (kg) and height (cm) [ Time Frame: Patient weight and height are provided from the equipment or given by the medical team during the procedure ]
    Weight and height will be combined to report BMI in kg/m^2.

  5. Size of Fields of View (FOV) (cm) [ Time Frame: Baseline, The most used FOV during the procedure is provided by the medical staff ]
    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)

  6. Differences between the displayed and measured X-ray doses (percentage) [ Time Frame: baseline ]
    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).

  7. Total air kerma of the procedure including the one performed of an O-arm equipment [ Time Frame: Data are provided by the X-ray equipment at the end of the procedure ]
    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).

  8. Total number of image frames (number) [ Time Frame: Data are provided by the X-ray equipment at the end of the procedure ]
    Total number of image frames (number)

  9. Fluoroscopy mode used during the procedure [ Time Frame: Data are provided by the X-ray equipment at the end of the procedure ]
    Participants should specify whether continuous, pulsed or mixed fluoroscopy modes are used during the procedure

  10. Fluoroscopy pulse rate ( pulses/second) [ Time Frame: Data are provided by the X-ray equipment at the end of the procedure ]
  11. Fluoroscopy time (hh:mm:ss) of the procedure including the one performed of an O-arm equipment [ Time Frame: Data are provided by the X-ray equipment at the end of the procedure ]
  12. KAP (Kerma-Area-Product) attributable to fluoroscopy [ Time Frame: Data are provided by the X-ray equipment at the end of the procedure ]
    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).

  13. Medical specialty of the procedure [ Time Frame: Data are provided by the medical staff during 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.

  14. Name/type of the procedure [ Time Frame: Data are provided by the medical staff during the procedure ]
    Participants should specify the medical description of the procedure.

  15. Additional information about the procedure giving further indications about the used materials or the anatomical region of interest. [ Time Frame: Data are provided by the medical staff during the procedure ]
  16. Total KAP for procedures performed on an O-arm equipment [ Time Frame: KAP is provided by the X-ray equipment at the end of the procedure ]
    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).

  17. Total DLP (Dose-Length-Product) of the procedures performed on an O-arm equipment.DLP is always expressed in mGy.cm. [ Time Frame: DLP is provided by the X-ray equipment at the end of the procedure ]
    The DLP (Dose Length Product) is expressed in milliGray *centimeters (mGy.cm)

  18. CTDIvol (Volume Computed Tomography Dose Index) of the procedures performed on an O-arm equipment. CTDI is always expressed in mGy. [ Time Frame: CTDIvol is provided by the X-ray equipment at the end of the procedure ]
    The CTDIvol is a standardized measure of radiation dose output of a CT scanner. This dose is expressed in milliGrays (mGy).

  19. Type of the dosimetric phantom used to calculate the CTDI of an acquisition for the procedures performed on an O-arm equipment. [ Time Frame: Data are provided by the X-ray equipment at the end of the procedure ]
    Participants should select between a "head phantom (16 cm)" or a "body phantom (32 cm)"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649451


Locations
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France
Hopital Lariboisiere
Paris, France, 75010
Sponsors and Collaborators
Societe Francaise de Physique Medicale
Hopital Lariboisière
University hospital, Angers, FRANCE
University hospital of Montpellier, FRANCE
Fréjus-Saint-Raphaël hospital, FRANCE
C2i Santé, FRANCE
Investigators
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Principal Investigator: 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
  Study Documents (Full-Text)

Documents provided by Societe Francaise de Physique Medicale:
Study Protocol  [PDF] August 20, 2018

Additional Information:

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Responsible Party: Societe Francaise de Physique Medicale
ClinicalTrials.gov Identifier: NCT03649451    
Other Study ID Numbers: gtsfpmnrbloc2017
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Societe Francaise de Physique Medicale:
Reference dose levels
Surgery
C-arm
Orthopedic
Urology
Vascular
Neurosurgery
Cardiology
Digestive
Fluoroscopy
Patient radiation protection
X-ray
Interventional radiology
Optimization
Kerma Area Product