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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Contusion

Detailed Description

The study is observational, cross-sectional, retrospective, and involves a post-marketing device (LUNIT INSIGHT CXR, CE-marked), with a non-profit framework. Patients presenting to the general Emergency Department (ED) of the IRCCS AOU of Bologna with blunt thoracic trauma, who underwent a chest HRCT within 48 hours of a standard chest X-ray, between June 1, 2014, and June 1, 2024, will be retrospectively included. Enrollment will be consecutive and based on discharge reports from the ED.

Chest X-rays will be analyzed using LUNIT by two expert radiologists. The identification of contusions by LUNIT will be compared with the standard chest X-ray reading (based on reports issued at the time of ED presentation), using chest HRCT as the gold standard. No changes will be made to the routine diagnostic-therapeutic pathway of patients. The Radiology Unit involved will be the Radiology Department of IRCCS AOUBO, Policlinico di Sant'Orsola; activities performed by the radiologists will include image reading, interpretation, and reporting, as per standard clinical practice, both before and after the application of LUNIT.

The identification of pulmonary contusions is crucial in the assessment of patients with blunt thoracic trauma, as it significantly impacts clinical management, often necessitating clinical observation due to the risk of respiratory failure and bacterial superinfection. Accurate identification of contusions on chest X-rays can reduce the need for HRCT in high-risk patients.

The use of software like LUNIT could represent a valid alternative to HRCT for patients presenting to the ED with blunt thoracic trauma, potentially reducing ionizing radiation exposure and shortening ED management times. Patients presenting to the general ED of IRCCS AOU of Bologna with blunt thoracic trauma and undergoing HRCT within 48 hours of a chest X-ray between June 1, 2014, and June 1, 2024, will be retrospectively included.

• Study Type: Observational
• Enrollment (Estimated): 135

Contacts and Locations

• Study Contact: Name: Veronica VS Salvatore, MD; Phone Number: +390512144716; Email: veronica.salvatore@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna
    • Contact: Veronica Salvatore VS Salvatore, MD; Phone Number: +390512414716; Email: veronica.salvatore@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Veronica Salvatore, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Wounds, Nonpenetrating; Contusions
• Other Study ID Numbers: LUNIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No