ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma

Last updated: January 30, 2024
Sponsor: Azienda Usl di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

oro tracheal intubation

Clinical Study ID

NCT05637944
4860 - TRACTIONS
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: oro tracheal intubation
Phase:
Study Start date:
October 01, 2022
Estimated Completion Date:
October 01, 2024

Study 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.

Connect with a study center

  • Azienda Unità Sanitaria Locale

    Bologna, 40100
    Italy

    Active - Recruiting

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