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Impact of Artificial Intelligence Detecting Fractures in the Emergence Department : a Pragmatic Prospective Study

Primary Purpose

Fractures, Bone

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
processing the radiography with the "Boneview" software
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fractures, Bone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Major patient Admitted to the emergency department after trauma less than 48 hours Patient with an indication on an x-ray of the limbs or/and pelvis Express patient consent Affiliated patient or social security beneficiary Exclusion Criteria: Polytraumatized patient X-ray of the corso-lumbar spine, skull, cervical spine (all parts of the body not affected by the intended use of the software) Pregnant, lactating or parturient patient

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change in ER support between X-ray reading without and with artificial intelligence
    Compare ER support decisions without and with fracture diagnostic software

    Secondary Outcome Measures

    Full Information

    First Posted
    August 22, 2023
    Last Updated
    October 5, 2023
    Sponsor
    University Hospital, Angers
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06013852
    Brief Title
    Impact of Artificial Intelligence Detecting Fractures in the Emergence Department : a Pragmatic Prospective Study
    Official Title
    Impact of Artificial Intelligence Detecting Fractures in the Emergence Department : a Pragmatic Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Angers

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Traumatic emergencies are the primary reason for consultation in emergency departments and standard radiography is the primary imaging exam for osteoarticular trauma. However, with the increase in the number of patients admitted to emergency departments and thus the increased workload for emergency room attendants, Interpretation of radiographs in trauma emergencies is made more difficult, resulting in a high risk of misinterpretation. The growing presence of artificial intelligence in the medical field, notably through the involvement of diagnostic software on imageries, makes its use more relevant in the aid of the replay of osteoarticular imageries. A recent meta-analysis of 32 studies evaluating the performance of artificial intelligence in fracture detection found comparable performance between experienced radiologists and AI-based diagnosis. However, these were mainly retrospective studies, and thus more distant from the reality of its use in a care stream such as emergencies. The objective of this study is therefore to prospectively validate the use of artificial intelligence software during its implementation in an emergency department for patients admitted for a suspicion of osteoarticular trauma.
    Detailed Description
    After completing the X-ray requested, the senior emergency physician reads the X-ray (native image only), gives his diagnosis (fracture yes/ no and localization) and reports if he requests the specialist (orthopedist/ radiologist) or not and the reason why he asks for it (urgent management, doubt about a fracture). After processing the radiography with the "Boneview" software, the emergency physician makes a second reading taking into account the analysis of artificial intelligence. It indicates its result and its decision in the same way. Then, he performs the practical management of the patient: specialized call, exit, urgent management. During the systematic rereading of the radiographs made in the emergency department the night before and night by the radiology intern, he makes a first reading of the native images and gives the result (fracture yes/ no and localization). Then, he makes a second reading assisted by "Boneview" and gives the result again. A radiologist specialized in osteoarticular imaging will read the radiographs initially native. He will note the result (fracture yes/ no and localization) then read the radiographs annotated by the software. He will give the result again. For the patient, there will be no additional imaging exams, but the x-ray will be read a secondary time with artificial intelligence assistance. This pet reading causes a change in patient management. Indeed if a discrepancy is noted between the reading of the radiography by the internal radiology or the conclusion of the emergency physician and the reading of the senior radiologist specialized in osteoarticular imaging, the patient will be recalled and reconvoked to the emergency department if necessary

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fractures, Bone

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1600 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    processing the radiography with the "Boneview" software
    Intervention Description
    all X-Rays will be analysed with and without the software
    Primary Outcome Measure Information:
    Title
    Change in ER support between X-ray reading without and with artificial intelligence
    Description
    Compare ER support decisions without and with fracture diagnostic software
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Major patient Admitted to the emergency department after trauma less than 48 hours Patient with an indication on an x-ray of the limbs or/and pelvis Express patient consent Affiliated patient or social security beneficiary Exclusion Criteria: Polytraumatized patient X-ray of the corso-lumbar spine, skull, cervical spine (all parts of the body not affected by the intended use of the software) Pregnant, lactating or parturient patient
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Damien Combes, Dr
    Phone
    +33 2 41 35 42 81
    Email
    damien.combe@chu-angers.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marie Bost, study coordinator
    Phone
    +33 2 41 35 31 99
    Email
    mabost@chu-angers.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Impact of Artificial Intelligence Detecting Fractures in the Emergence Department : a Pragmatic Prospective Study

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