PARADIS_1: PARamedical Abnormalties Detection of Traumatic Bone Lesion of the extremitIeS

• Sponsor: Poitiers University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05076188
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Actual Duration (Months): 6
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

This study assesses the performance of radiographers in detecting radiological anomalies of the appendicular skeleton in emergency department. This is a retrospective study comparing the radiographers' diagnostic performance before and after dedicated training, assisted or not by artificial intelligence software. All performances will be evaluated and compared.

Condition or Disease	Intervention/Treatment	Phase
Radiography; Emergencies; Diagnostic	Diagnostic Test: Emergency radiography

Study Design

• Study Type: Observational
• Actual Enrollment: 19 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: PARamedical Abnormalties Detection of Traumatic Bone Lesion of the extremitIeS
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: Jul 1, 2021
• Actual Study Completion Date: Sep 1, 2021

Outcome Measures

Primary Outcome Measures

1. Evaluate the radiographers' diagnostic performance to issue an advisory opinion to X-ray reading of the appendicular skeleton in emergency department [2 hours]

   The primary outcome measure evaluation radiographers' diagnostic will use accurancy, sensibility and specificity.

Secondary Outcome Measures

1. Quantify the proportion of radiographers reaching the goal of 90% accurancy [4 months]

   This is a proportion in % of performance radiographers' diagnosctic treshold

2. Quantify and qualify Radiographers diagnostic changes before and after the in house training. [4 months]

   This a proportion in % about the progression of performance radiographers'diagnostic in the formation.

3. Evaluate the performance of the association of AI and radiographer after training [4 months]

   Thiis output is the difference between accurancy, sensibility and sensitivity with or without IA.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Working in an emergency radiography department Volunteer to participate in the study

Exclusion Criteria:

• Planned departure from the establishment within 12 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	C.H.U. de Poitiers	Poitiers		France	86000

Sponsors and Collaborators

• Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT05076188
• Other Study ID Numbers: Paradis_1
• First Posted: Oct 13, 2021
• Last Update Posted: Nov 2, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Emergencies

Study Results

No Results Posted as of Nov 2, 2021