ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma (TRACTIONS)

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.

Study Overview

• Status: Recruiting
• Conditions: Trauma Chest
• Intervention / Treatment: Procedure: oro tracheal intubation

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Lorenzo Gamberini, MD; Phone Number: 0039 051 6478215; Email: lorenzo.gamberini@ausl.bologna.it

Study Locations

• Italy
  • Bologna, Italy, 40100
    • Recruiting
    • Azienda Unità Sanitaria Locale
    • Contact: Lorenzo Gamberini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

chest trauma, blunt

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
intubated within day 7th; patients needing oro-tracheal intubation within day 7th from admission.	Procedure: oro tracheal intubation; chest trauma requiring oro tracheal intubation
non intubated within day 7th; patients not requiring intubation within day 7th from admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
needing for oro-tracheal intubation within day 7th from admission	7 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: November 25, 2022
• First Submitted That Met QC Criteria: November 25, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: trauma; chest trauma
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 4860 - TRACTIONS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No