Trauma ChestTRACTIONSNCT05637944
ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma
An observational study of Trauma Chest, run by Azienda Usl di Bologna at 1 site in Italy.
Trial summary
The primary objective of this study is the evaluation of risk factors associated with orotracheal intubation in blunt chest trauma patients not intubated on the field and not fulfilling the criteria for intubation based on the Glasgow Coma scale score with the building of a predictive score based on those findings… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Chest
- What is being tested?
- oro tracheal intubation
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 1 Oct 2024
- How long will I take part?
- 7 Days
- 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: chest trauma, blunt
Who may be able to join
- Blunt thoracic trauma with a documentable lesion (T-AIS ≥ 2)
- Age ≥ 18 years
- GCS > 8 at ED admission
- Total body CT scan available performed within 6 hours from ED admission
Who cannot join
- - Penetrating thoracic trauma
- Age < 18 years
- GCS <= 8 at ED admission
- Patients already intubated at ED arrival
- Do not intubate order, for any reason
- Intubation for Urgent/Emergent surgery within 24 hours from hospital arrival
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Unità Sanitaria Locale
Bologna, 40100
Lorenzo Gamberini
About this study
The primary objective of this study is the evaluation of risk factors associated with orotracheal intubation in blunt chest trauma patients not intubated on the field and not fulfilling the criteria for intubation based on the Glasgow Coma scale score with the building of a predictive score based on those findings taking into account the clinical, laboratory and radiologic tests performed within 6 hours from hospital admission.
Read the detailed description
Multicentre, prospective, observational study. All the consecutive blunt thoracic trauma patients consecutively admitted at the participating institutions' Emergency Department (ED) will be considered for enrolment. The primary outcome measure will be the need for orotracheal intubation for primary respiratory failure lasting at least 48 hours within 7 days after trauma. The secondary outcome measures related to analgesia are: the basal analgesia protocol received during the first 7 days from ED admission and the median cumulative dose of morphine-equivalents received as rescue therapy during the first 7 days after trauma. The secondary outcome measure related to the sonographic evolution of thoracic lesions is the global and regional LUS.
- Conditions
- Trauma Chest
- Being tested
- oro tracheal intubation
- Keywords
- trauma; chest trauma
- Medical subject headings
- Thoracic Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oro tracheal intubationProcedure or surgery
chest trauma requiring oro tracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| intubated within day 7th | patients needing oro-tracheal intubation within day 7th from admission. Receives: Procedure: oro tracheal intubation | |
| non intubated within day 7th | patients not requiring intubation within day 7th from admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
needing for oro-tracheal intubation within day 7th from admission
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 posted6 Dec 2022
- Study start1 Oct 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma ChestStudies 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Collaborators
- Azienda Ospedaliero-Universitaria Careggi, Ospedale di Circolo e Fondazione Macchi, Varese, Trauma Center Pisa, Ospedale Santa Maria della Scaletta di Imola, Azienda Ospedaliera di Perugia, Ospedale Policlinico San Martino, Azienda Ospedaliero Universitaria Maggiore della Carita, Ospedale S. Giuseppe (Empoli), Pronto Soccorso Ospedale Misericordia Grosseto, Ospedale Bufalini - Cesena, Azienda Ospedaliero-Universitaria di Padova, A.O. Ospedale Papa Giovanni XXIII, Pronto Soccorso e Medicina d'Urgenza Latisana, Humanitas Research Hospital IRCCS, Rozzano-Milan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637944
- Sponsor's protocol ID
- 4860 - TRACTIONS
- Acronym
- TRACTIONS
- Status last verified
- Jan 2024
- First submitted
- 25 Nov 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma
- ClinicalTrials.gov ID
- NCT05637944
- Acronym / sponsor ID
- TRACTIONS / 4860 - TRACTIONS
- Conditions
- Trauma Chest
- Keywords
- trauma; chest trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Collaborators
- Azienda Ospedaliero-Universitaria Careggi, Ospedale di Circolo e Fondazione Macchi, Varese, Trauma Center Pisa, Ospedale Santa Maria della Scaletta di Imola, Azienda Ospedaliera di Perugia, Ospedale Policlinico San Martino, Azienda Ospedaliero Universitaria Maggiore della Carita, Ospedale S. Giuseppe (Empoli), Pronto Soccorso Ospedale Misericordia Grosseto, Ospedale Bufalini - Cesena, Azienda Ospedaliero-Universitaria di Padova, A.O. Ospedale Papa Giovanni XXIII, Pronto Soccorso e Medicina d'Urgenza Latisana, Humanitas Research Hospital IRCCS, Rozzano-Milan
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 6 Dec 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.
The primary objective of this study is the evaluation of risk factors associated with orotracheal intubation in blunt chest trauma patients not intubated on the field and not fulfilling the criteria for intubation based on the Glasgow Coma scale score with the building of a predictive score based on those findings taking into account the clinical, laboratory and radiologic tests performed within 6 hours from hospital admission.
Detailed description
Multicentre, prospective, observational study. All the consecutive blunt thoracic trauma patients consecutively admitted at the participating institutions' Emergency Department (ED) will be considered for enrolment. The primary outcome measure will be the need for orotracheal intubation for primary respiratory failure lasting at least 48 hours within 7 days after trauma. The secondary outcome measures related to analgesia are: the basal analgesia protocol received during the first 7 days from ED admission and the median cumulative dose of morphine-equivalents received as rescue therapy during the first 7 days after trauma. The secondary outcome measure related to the sonographic evolution of thoracic lesions is the global and regional LUS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intubated within day 7th | – | Procedure: oro tracheal intubationpatients needing oro-tracheal intubation within day 7th from admission. |
| non intubated within day 7th | – | –patients not requiring intubation within day 7th from admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chest trauma, blunt
Key inclusion criteria (4 listed)
- Blunt thoracic trauma with a documentable lesion (T-AIS ≥ 2)
- Age ≥ 18 years
- GCS > 8 at ED admission
- Total body CT scan available performed within 6 hours from ED admission
Key exclusion criteria (6 listed)
- - Penetrating thoracic trauma
- Age < 18 years
- GCS <= 8 at ED admission
- Patients already intubated at ED arrival
- Do not intubate order, for any reason
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 |
|---|---|---|
| oro tracheal intubationchest trauma requiring oro tracheal intubation | Procedure or surgery | intubated within day 7th |
Primary outcome
needing for oro-tracheal intubation within day 7th from admission
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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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.
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 Trauma Chest, 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Gamberini, MD (0039 051 6478215, lorenzo.gamberini@ausl.bologna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
needing for oro-tracheal intubation within day 7th from admission (time frame: 7 days). 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 31 Jan 2024.