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

NCT ID: NCT06777056

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 135 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2025-06-15

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.

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.

Conditions

Lung Contusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veronica Salvatore, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Veronica VS Salvatore, MD

Role: CONTACT

veronica.salvatore@aosp.bo.it

+390512144716

Facility Contacts

Veronica Salvatore VS Salvatore, MD

Role: primary

veronica.salvatore@aosp.bo.it

+390512414716

Other Identifiers

LUNIT

Identifier Type: -

Identifier Source: org_study_id