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ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma (TRACTIONS)

A

Azienda Usl di Bologna

Status

Enrolling

Conditions

Trauma Chest

Treatments

Procedure: oro tracheal intubation

Study type

Observational

Funder types

Other

Identifiers

NCT05637944
4860 - TRACTIONS

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

intubated within day 7th
Description:
patients needing oro-tracheal intubation within day 7th from admission.
Treatment:
Procedure: oro tracheal intubation
non intubated within day 7th
Description:
patients not requiring intubation within day 7th from admission

Trial contacts and locations

1

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Central trial contact

Lorenzo Gamberini, MD

Data sourced from clinicaltrials.gov

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