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
About this trial
This is an interventional diagnostic trial for Fractures, Bone
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
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
NCT ID
NCT06013852
First Posted
August 22, 2023
Last Updated
October 5, 2023
Sponsor
University Hospital, Angers
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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