ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma

NCT ID: NCT05637944

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-10-01

Brief Summary

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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

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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.

Conditions

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Trauma Chest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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intubated within day 7th

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

oro tracheal intubation

Intervention Type PROCEDURE

chest trauma requiring oro tracheal intubation

non intubated within day 7th

patients not requiring intubation within day 7th from admission

No interventions assigned to this group

Interventions

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oro tracheal intubation

chest trauma requiring oro tracheal intubation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role collaborator

Ospedale di Circolo e Fondazione Macchi, Varese

UNKNOWN

Sponsor Role collaborator

Trauma Center Pisa

UNKNOWN

Sponsor Role collaborator

Ospedale Santa Maria della Scaletta di Imola

UNKNOWN

Sponsor Role collaborator

Azienda Ospedaliera di Perugia

OTHER

Sponsor Role collaborator

Ospedale Policlinico San Martino

OTHER

Sponsor Role collaborator

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

UNKNOWN

Sponsor Role collaborator

Ospedale S. Giuseppe (Empoli)

UNKNOWN

Sponsor Role collaborator

Pronto Soccorso Ospedale Misericordia Grosseto

UNKNOWN

Sponsor Role collaborator

Ospedale Bufalini - Cesena

UNKNOWN

Sponsor Role collaborator

Azienda Ospedaliero-Universitaria di Padova

UNKNOWN

Sponsor Role collaborator

ASST Papà Giovanni XXIII Bergamo

UNKNOWN

Sponsor Role collaborator

Pronto Soccorso e Medicina d'Urgenza Latisana

UNKNOWN

Sponsor Role collaborator

IRCCS Humanitas - Rozzano (MI)

UNKNOWN

Sponsor Role collaborator

Azienda Usl di Bologna

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Azienda Unità Sanitaria Locale

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Lorenzo Gamberini, MD

Role: CONTACT

0039 051 6478215

Facility Contacts

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Lorenzo Gamberini

Role: primary

Other Identifiers

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4860 - TRACTIONS

Identifier Type: -

Identifier Source: org_study_id

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