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OpenTrials
Completed

NCT Number: NCT04934384

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

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.

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Key information

Conditions

Trauma Splenic Abdominal Injuries Liver Injury Trauma Abdomen Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maggiore Hospital Ospedale Maggiore Carlo Alberto Pizzardi AUSL di Bologna

Bologna, 40110, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prehospital extended focused assessment sonography for trauma

Diagnostic Test

Sonographic procedure performed in the prehospital environment aiming at evaluating peritoneal free fluid in trauma patients

Other names: eFAST

Primary outcomes

  1. 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)

Secondary outcomes

  1. Prehospital time

    Time frame: 240 minutes

    Time from EMS dispatch to ED arrival

  2. 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

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2021
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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