PneumoniaRESOLUTIONNCT06750822
Accuracy of Automatic Contusion Volume Scanning for Predicting the Incidence of Pneumonia in Patients With Thoracic Trauma
An observational study of Pneumonia and Thoracic Trauma, run by Azienda Usl di Bologna at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Thoracic Trauma
- How many people
- 486 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2024to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Admission to the ED for trauma as primary diagnosis
- Whole-body contrast CT scan performed within 6 hours from admission
Who cannot join
- Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pneumonia, Thoracic Trauma
- Keywords
- AAST, AISThorax, Pneumonia, trauma
- Medical subject headings
- Pneumonia, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Trauma patients | Any patient admitted for trauma in the Emergency Department receiving a whole-body contrast CT scan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
7d-pneumonia
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 May 2024
- Primary completion1 Sep 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750822
- Sponsor's protocol ID
- 24057-667-2024-OSS-RESOLUTION
- Acronym
- RESOLUTION
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be shared upon reasonable request
Publications
Gamberini L, Astuti GM, Biavati B, Boarato D, Tontodonati M, Palmitessa I, Laruccia M, Coniglio C, Bertini A, Orlandi PE, Tartaglione M, Allegri D, Bruno A. Pulmonary contusion volume and radiomics as predictors of early-onset pneumonia in trauma patients, a retrospective single-centre study. Eur J Trauma Emerg Surg. 2025 Aug 22;51(1):275. doi: 10.1007/s00068-025-02952-1.
PubMed 40844714
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Automatic Contusion Volume Scanning for Predicting the Incidence of Pneumonia in Patients With Thoracic Trauma
- ClinicalTrials.gov ID
- NCT06750822
- Acronym / sponsor ID
- RESOLUTION / 24057-667-2024-OSS-RESOLUTION
- Conditions
- Pneumonia, Thoracic Trauma
- Keywords
- AAST, AISThorax, Pneumonia, trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma patients | – | –Any patient admitted for trauma in the Emergency Department receiving a whole-body contrast CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Admission to the ED for trauma as primary diagnosis
- Whole-body contrast CT scan performed within 6 hours from admission
Key exclusion criteria (1 listed)
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Derived from this study: PubMed 40844714Gamberini L, Astuti GM, Biavati B, Boarato D, Tontodonati M, Palmitessa I, Laruccia M, Coniglio C, Bertini A, Orlandi PE, Tartaglione M, Allegri D, Bruno A. Pulmonary contusion volume and radiomics as predictors of early-onset pneumonia in trauma patients, a retrospective single-centre study. Eur J Trauma Emerg Surg. 2025 Aug 22;51(1):275. doi: 10.1007/s00068-025-02952-1.
- Individual participant dataSharing planned: Yes. Anonymized data will be shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Thoracic Trauma, run by Azienda Usl di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7d-pneumonia (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06750822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.