Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06013852
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-08-22
Brief Title:
Boneview-ED - Impact of Artificial Intelligence Detecting Fractures in the Emergence Department a Pragmatic Prospective Study
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
Boneview-ED - Impact of Artificial Intelligence Detecting Fractures in the Emergence Department a Pragmatic Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Boneview-ED
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None