AI in the Identification of Lung Contusions Through Chest Radiological Examination in Blunt Thoracic Trauma

NCT06777056 | Recruiting

• 1 other identifier: LUNIT
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The observational study focuses on comparing the interpretation of chest radiological examinations performed using a computer-based system with the standard interpretation conducted by a radiologist. The "LUNIT" system serves as a tool designed to assist radiologists in detecting the 10 most common abnormalities visible on chest radiographs, with proven efficacy in large case series. The investigation addresses the need to evaluate lung injuries resulting from thoracic trauma, which are linked to a higher risk of complications requiring close monitoring to detect potential respiratory failure. The primary aim of the study is to assess the accuracy of the LUNIT system in interpreting chest radiographs for the identification of lung contusions compared to the standard radiologist-based interpretation.

Conditions

Lung Contusion

Outcome Measures

Primary Outcomes (1)

• Sensitivity of lung contusion detection on chest X-rays, with LUNIT software

  Sensitivity of lung contusion detection on chest X-rays, with and without the use of LUNIT software, compared to the gold standard: chest HRCT performed within 48 hours

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the Emergency Department of the IRCCS AOU of Bologna between June 1, 2014, and June 1, 2024, for blunt thoracic trauma, with chest HRCT performed within 48 hours of the chest X-ray.

You may qualify if:

• Age ≥ 18 years
• Patients presenting to the general Emergency Department of the IRCCS AOU of Bologna between June 1, 2014, and June 1, 2024, for blunt thoracic trauma
• Performance of chest HRCT within 48 hours of standard chest X-ray

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Study Officials

• Veronica Salvatore, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica VS Salvatore, MD

CONTACT

+390512144716; veronica.salvatore@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: December 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: January 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)