ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma

Trauma Chest Clinical Trial

— TRACTIONS  

Official title:

ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637944
• Other study ID #: 4860 - TRACTIONS
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2024
• Source: Azienda Usl di Bologna
• Contact: Lorenzo Gamberini, MD
• Phone: 0039 051 6478215
• Email: lorenzo.gamberini[@]ausl.bologna.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 taking into account the clinical, laboratory and radiologic tests performed within 6 hours from hospital admission.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Trauma Chest
• Wounds and Injuries

Intervention

Procedure:
• oro tracheal intubation
chest trauma requiring oro tracheal intubation

Locations

Country	Name	City	State
Italy	Azienda Unità Sanitaria Locale	Bologna

Sponsors (15)

Lead Sponsor

Collaborator

Azienda Usl di Bologna

ASST Papà Giovanni XXIII Bergamo, Azienda Ospedaliera di Perugia, Azienda ospedaliera universitaria Careggi, Azienda Ospedaliero-Universitaria di Padova, Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara, IRCCS Humanitas - Rozzano (MI), Ospedale Bufalini - Cesena, Ospedale di Circolo e Fondazione Macchi, Varese, Ospedale S. Giuseppe (Empoli), Ospedale Santa Maria della Scaletta di Imola, Policlinico San Martino Genova, Pronto Soccorso e Medicina d'Urgenza Latisana, Pronto Soccorso Ospedale Misericordia Grosseto, Trauma Center Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	needing for oro-tracheal intubation within day 7th from admission		7 days