NCT05637944

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

November 25, 2022

Last Update Submit

January 30, 2024

Conditions

Trauma Chest

Keywords

trauma; chest trauma

Outcome Measures

Primary Outcomes (1)

  • needing for oro-tracheal intubation within day 7th from admission

    7 days

Study Arms (2)

intubated within day 7th

patients needing oro-tracheal intubation within day 7th from admission.

Procedure: oro tracheal intubation

non intubated within day 7th

patients not requiring intubation within day 7th from admission

Interventions

oro tracheal intubationPROCEDURE

chest trauma requiring oro tracheal intubation

intubated within day 7th

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

chest trauma, blunt

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Unità Sanitaria Locale

Bologna, 40100, Italy

RECRUITING

MeSH Terms

Conditions

Thoracic InjuriesWounds and Injuries

Central Study Contacts

Lorenzo Gamberini, MD

CONTACT

0039 051 6478215lorenzo.gamberini@ausl.bologna.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2022

First Posted

December 6, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

IT(1)