The Role of Prehospital eFAST in Accelerating Time to Diagnostics or Definitive Treatment in the Emergency Department

July 29, 2021 updated by: Azienda Usl di Bologna

Actual literature has demonstrated that prehospital extended focused assessment sonography for trauma (eFAST) could impact on logistic and treatment decisions such as mode of transportation and choice of hospital destination.

However, there are no data with regard to in-hospital effects of a positive prehospital eFAST.

The main objective of this study was to evaluate the effects of prehospital eFAST driven decisions on in hospital time-to-definitive diagnostics or time-to definitive treatment, whichever came first, in a level 1 trauma center.

The goal is to define if this information could have a role in prioritizing patients' access to care in a population of abdominal trauma patients with A-AIS > 1 and a documented liver or spleen injury.

Study Overview

Study Type

Observational

Enrollment (Actual)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bologna, Italy, 40110
        • Maggiore Hospital Ospedale Maggiore Carlo Alberto Pizzardi AUSL di Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will involve all the patients admitted to the Maggiore Hospital's emergency department (ED) from January 2014 to December 2019 with a traumatic liver or spleen injury who survived enough time to get a CT scan or a surgical intervention within 3 hours from the ED admission

Description

Inclusion Criteria:

  • Patients admitted to emergency department with a ICD-9-CM diagnosis of traumatic liver or spleen injury (codes 8640x, 8641x, 8650x, 8651x)
  • Abdominal AIS ≥ 2
  • CT scan or operating theatre admission performed within 180 minutes from ED admission

Exclusion Criteria:

  • Death before CT scan or OR/Angio suite admission (missing primary outcome measure)
  • Transferred to other hospitals before CT scan or operating room admission
  • Missing data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Positive prehospital eFAST
Patients with a positive prehospital eFAST, independently from their hemodynamic status or other vital signs
Sonographic procedure performed in the prehospital environment aiming at evaluating peritoneal free fluid in trauma patients
Other Names:
  • eFAST
Negative or not performed prehospital eFAST
Patients with a positive prehospital eFAST, independently from their hemodynamic status or other vital signs
Sonographic procedure performed in the prehospital environment aiming at evaluating peritoneal free fluid in trauma patients
Other Names:
  • eFAST

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to definitive diagnostics or treatment
Time Frame: 180 minutes
Time from the ED arrival to CT scan imaging or surgical intervention (whichever came first)
180 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prehospital time
Time Frame: 240 minutes
Time from EMS dispatch to ED arrival
240 minutes
Sensitivity and specificity of prehospital eFAST
Time Frame: 240 minutes
Sensitivity and specificity of prehospital eFAST calculated considering ED eFAST as the gold standard measure
240 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2021

Primary Completion (Actual)

July 15, 2021

Study Completion (Actual)

July 26, 2021

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PreH-eFAST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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