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Use of Augmented Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department (IMMEDIAT Urgences)

Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05882435
Acronym
IMMEDIAT
Enrollment
8400
Registered
2023-05-31
Start date
2023-05-31
Completion date
2023-12-15
Last updated
2023-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Fracture

Brief summary

The study evaluates, in 3 emergency departments (ED) and on randomized alternate periods, the use of SmartUrgences®, Augmented Intelligence (AI) software to help the interpretation of bone standard X-rays prescibed by the ED.

Detailed description

The study evaluates, in 3 emergency departments (ED) and on randomized alternate periods, the use of SmartUrgences®, Augmented Intelligence (AI) software to help the interpretation of bone radiographs prescibed by the ED. The primary objective of the organizational study is to evaluate, compared to the current organization for the interpretation of standard bone radiographs requested by the ED, the impact of an organization incorporating the Milvue solution, on the reduction of the patient diagnostic error rate. A cost-consequence study is carried out, comparing from the point of view of the community (production costs according to the HAS recommendations), the radiological diagnosis within the framework of an organization with the Milvue solution, to that within the framework of the current organization without the use of the Milvue solution. The economic study will follow the scheme of the organizational study, comparing the periods with and without the Milvue solution and analyzing the costs and consequences, by period and by patient. This is an open-label randomized cluster multiple period cross-over study with 6 alternate periods (3 with AI, 3 with usual organization) of 1 month in each ED. The choice of the intervention for the first period will be randomized.

Interventions

OTHEROrganization with AI

X-rays are done in the radiology department and the images are made available to emergency physicians with the AI interpretation. X-rays flagged by IA as anormal or suspicious will be reviewed without delay by the radiologist, non-flagged X-rays will be reviewed by radiologists on a delayed basis.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. All adult referred by the ED for a conventional X-rays of all or part of the appendicular skeleton and/or pelvis and/or costal gril 2. Not opposed to participate

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic error rateThrough patient's discharge from the emergency department, an average of 1 dayA diagnostic error is defined as a final consensus diagnosis that differs from the diagnosis documented in the medical record by the emergency physician prior to patient's discharge from the ED. A diagnostic error is defined as a final consensus diagnosis that differs from the diagnosis documented in the medical record by the emergency physician prior to patient's discharge from the ED.

Secondary

MeasureTime frameDescription
Time between x-ray and first diagnostic by the emergency physicianThrough patient's discharge from the emergency department, an average of 1 dayTime between x-ray and first diagnostic by the emergency physician in the patient medical file
Time between x-ray and final diagnostic by the emergency physician30 daysTime between x-ray and final diagnostic by the emergency physician in the patient medical file. A diagnostic will be considered as final if the same as the consensus one
Rate of X-rays interpretation by radiologist without delay1 hourRate of X-rays interpretation by radiologist without delay (i.e within 1 hour)
Number of all radiological exam per patient prescribed by the EDThrough patient's discharge from the emergency department, an average of 1 dayNumber of all radiological exam per patient prescribed by the ED (MRI, scanner, x-rays, echography)
Time between x-ray and first diagnosticThrough patient's discharge from the emergency department, an average of 1 dayTime between x-ray and first diagnostic, either by the emergency physician or by the radiologist
Time spent in the ED by the patientThrough patient's discharge from the emergency department, an average of 1 dayTime spent in the ED by the patient
Number of patients invited to come back in the ED30 daysNumber of patients invited to come back in the ED
30 days morbidity30 daysNew ED visit, hospitalization, radiological exam or outpatient visit, for the same reason as the first ED visit
Total cost from the hospital viewpoint30 daysTotal cost from the hospital viewpoint
Number of X-rays with a report by a radiologist at 30 days30 daysNumber of X-rays with a report by a radiologist at 30 days

Countries

France

Contacts

Primary ContactOlivier LUCIDARME, MD, PhD
olivier.lucidarme@aphp.fr01 42 17 63 22

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026