Evaluating intubation risks in blunt chest trauma patients
ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma
This study is trying to find out what factors might lead to the need for intubation in patients with blunt chest trauma who come to the Emergency Department and are awake enough to communicate.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Usl di Bologna Government |
| Locations | 1 site (Bologna) |
| Trial ID | NCT05637944 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify risk factors for orotracheal intubation in patients with blunt chest trauma who are not intubated in the field and have a Glasgow Coma Scale score above 8. It will involve multiple centers and assess patients admitted to the Emergency Department, collecting clinical, laboratory, and radiologic data within 6 hours of admission. The primary outcome will be the need for intubation due to respiratory failure within 7 days, while secondary outcomes will focus on analgesia protocols and the evolution of thoracic lesions through ultrasound. The goal is to develop a predictive score based on these findings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with blunt thoracic trauma and a Glasgow Coma Scale score greater than 8.
Not a fit: Patients with penetrating thoracic trauma, those under 18, or those already intubated upon arrival will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve patient outcomes by providing a reliable risk assessment tool for intubation in blunt chest trauma cases.
How similar studies have performed: While similar studies have explored intubation risks, this approach of developing a predictive score based on a multicenter observational framework is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * - 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
Where this trial is running
Bologna
- Azienda Unità Sanitaria Locale — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Lorenzo Gamberini, MD
- Email: lorenzo.gamberini@ausl.bologna.it
- Phone: 0039 051 6478215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.