Clinical trial NCT05637944: ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma
Official title: ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trauma Chest
Keywords: trauma; chest trauma
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
Collaborators: name: Azienda Ospedaliero-Universitaria Careggi
name: Ospedale di Circolo e Fondazione Macchi, Varese
name: Trauma Center Pisa
name: Ospedale Santa Maria della Scaletta di Imola
name: Azienda Ospedaliera di Perugia
name: Ospedale Policlinico San Martino
name: Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
name: Ospedale S. Giuseppe (Empoli)
name: Pronto Soccorso Ospedale Misericordia Grosseto
name: Ospedale Bufalini - Cesena
name: Azienda Ospedaliero-Universitaria di Padova
name: ASST Papà Giovanni XXIII Bergamo
name: Pronto Soccorso e Medicina d'Urgenza Latisana
name: IRCCS Humanitas - Rozzano (MI)
First posted: 2022-12-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: chest trauma, blunt

Brief 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 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.

Eligibility 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

Primary outcomes:
measure: needing for oro-tracheal intubation within day 7th from admission
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda Unità Sanitaria Locale
Study officials:
References: