Rib FracturesNCT05617404
Blunt Thoracic Trauma: Definition of a Standard Operating Procedure
An observational study of Rib Fractures and Polytrauma, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Rib fractures are the most frequent injury after blunt thoracic trauma. It is very important to choose the most appropriate interventions to prevent complications. But who will benefit most of those interventions remains a challenge. This study analyses the correlation between chest X-Ray and CT scan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures, Polytrauma, Thoracic Injury
- What is being tested?
- CT scan
- How many people
- 553 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2020to 1 Mar 2021
- 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: We included all patients older than 18 years old admitted to our hospital due to a polytrauma that were admitted to the ICU and had a CT scan in the first 24 hours.
Who may be able to join
- Polytrauma patients admitted to de ICU with a thoracic CT scan in the first 24h of arrival
Who cannot join
- Penetrating trauma
- Patients referred from other hospitals
Trial locations and contacts
1 site in 1 country.
About this study
Rib fractures are the most frequent injury after blunt thoracic trauma. It is very important to choose the most appropriate interventions to prevent complications. But who will benefit most of those interventions remains a challenge.
This study analyses the correlation between chest X-Ray and CT scan. We also analyse different scores to predict respiratory failure.
- Conditions
- Rib Fractures, Polytrauma, Thoracic Injury, Respiratory Failure
- Being tested
- CT scan
- Medical subject headings
- Rib Fractures, Multiple Trauma, Thoracic Injuries, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDiagnostic test
Polytrauma patients with thoracic CT-scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Best predictor of respiratory complications
Compare different items to identify the best predictor of respiratory complications: resipratory failure and pneumonia.
Measured: 01/02/2021 - 18/08/2022
Secondary outcomes (3)
Compare XRay and CT
Compare findings in x-ray (read by surgeon), x-ray (read by radiologist) and CT scan
Measured: 01/02/2021 - 18/08/2022
Number of fractures to predict complications
Analyse if there is a number of rib fracture that can predict respiratory complications
Measured: 01/02/2021 - 18/08/2022
Compare scores
Compare different scores: OIS, CTS, Ribscore, Rib Fracture Score
Measured: 01/02/2021 - 18/08/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Feb 2020
- Primary completion1 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 553 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Gracia-Roman, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617404
- Sponsor's protocol ID
- CGHUPTRGR01
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blunt Thoracic Trauma: Definition of a Standard Operating Procedure
- ClinicalTrials.gov ID
- NCT05617404
- Acronym / sponsor ID
- CGHUPTRGR01
- Conditions
- Rib Fractures, Polytrauma, Thoracic Injury, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 553 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 15 Nov 2022 (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.
Rib fractures are the most frequent injury after blunt thoracic trauma. It is very important to choose the most appropriate interventions to prevent complications. But who will benefit most of those interventions remains a challenge.
This study analyses the correlation between chest X-Ray and CT scan. We also analyse different scores to predict respiratory failure.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We included all patients older than 18 years old admitted to our hospital due to a polytrauma that were admitted to the ICU and had a CT scan in the first 24 hours.
Key inclusion criteria (1 listed)
- Polytrauma patients admitted to de ICU with a thoracic CT scan in the first 24h of arrival
Key exclusion criteria (2 listed)
- Penetrating trauma
- Patients referred from other hospitals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanPolytrauma patients with thoracic CT-scan | Diagnostic test | – |
Primary outcome
Best predictor of respiratory complications
Time frame: 01/02/2021 - 18/08/2022
Compare different items to identify the best predictor of respiratory complications: resipratory failure and pneumonia.
3 secondary outcomes
Compare XRay and CT
Time frame: 01/02/2021 - 18/08/2022
Number of fractures to predict complications
Time frame: 01/02/2021 - 18/08/2022
Compare scores
Time frame: 01/02/2021 - 18/08/2022
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 15 Nov 2022.
- Individual participant dataSharing planned: No
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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 Rib Fractures and Polytrauma, run by Corporacion Parc Tauli at 1 site in Spain.
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 1 inclusion and 2 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 15 Nov 2022. 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 Spain. 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?
Best predictor of respiratory complications (time frame: 01/02/2021 - 18/08/2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2022.