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NCT Number: NCT06777056

AI 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Veronica Salvatore VS Salvatore, MD

CONTACT

[email protected]

+390512414716

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: through study completion, an average of 1 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Veronica VS Salvatore, MD

CONTACT

[email protected]

+390512144716

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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