ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma

Recruiting

• Conditions: Trauma Chest
• Interventions: Procedure: oro tracheal intubation

• Registration Number: NCT05637944
• Lead Sponsor: Azienda Usl di Bologna

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.

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-11-25
• Study First Submitted QC: 2022-11-25
• Study First Posted: 2022-12-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intubated within day 7th	oro tracheal intubation	patients needing oro-tracheal intubation within day 7th from admission.

Primary Outcome Measures

Name	Time	Method
needing for oro-tracheal intubation within day 7th from admission	7 days

Trial Locations

Locations (1)

Azienda Unità Sanitaria Locale; 🇮🇹 Bologna, Italy