Accuracy of Automatic Contusion Volume Scanning for Predicting the Incidence of Pneumonia in Patients With Thoracic Trauma (RESOLUTION)

December 26, 2024 updated by: Azienda Usl di Bologna

The goal of this retrospective observational study is to evaluate the diagnostic accuracy of pulmonary contusion volume in predicting early pneumonia in patients with thoracic trauma.

The primary question we aim to answer is: What is the diagnostic accuracy of pulmonary contusion volume in predicting pneumonia within 7 days post-trauma?

Moreover, we aim to explore which is the overlap between the contused segments and those developing pneumonia.

Finally, we aim to explore relevant differences in radiomic features between contused segments that developed pneumonia.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

486

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40128
        • Maggiore Hospital Carlo Alberto Pizzardi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study includes all the consecutive patients admitted to the ED of the institution for trauma and having a contrast whole-body CT scan performed within 6 hours from admission

Description

Inclusion Criteria:

  • Admission to the ED for trauma as primary diagnosis
  • Whole-body contrast CT scan performed within 6 hours from admission

Exclusion Criteria:

  • Age <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Trauma patients
Any patient admitted for trauma in the Emergency Department receiving a whole-body contrast CT scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7d-pneumonia
Time Frame: 7 days

Pneumonia appearing within 7 days from trauma, defined as:

• New or worsening pulmonary infiltrates plus ≥ 2 of the following:

  • Body temperature ≥ 38°C or ≤ 35°C
  • White Blood Cell (WBC) count > 12,000 or < 4,000 cells/mL or presence of immature granulocytes in the blood sample
  • Purulent sputum
  • Worsening pulmonary oxygenation, defined as a decline in the PaO2/FiO2 ratio
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Usl di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 26, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 26, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24057-667-2024-OSS-RESOLUTION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data will be shared upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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