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

NCT04934384 | Completed

• 1 other identifier: PreH-eFAST
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trauma Splenic; Trauma Abdomen; Liver Injury

Keywords

trauma; liver; spleen

Outcome Measures

Primary Outcomes (1)

• Time to definitive diagnostics or treatment

  Time from the ED arrival to CT scan imaging or surgical intervention (whichever came first)

  180 minutes

Secondary Outcomes (2)

• Prehospital time

  240 minutes

• Sensitivity and specificity of prehospital eFAST

  240 minutes

Study Arms (2)

Positive prehospital eFAST

Patients with a positive prehospital eFAST, independently from their hemodynamic status or other vital signs

Diagnostic Test: prehospital extended focused assessment sonography for trauma

Negative or not performed prehospital eFAST

Patients with a positive prehospital eFAST, independently from their hemodynamic status or other vital signs

Diagnostic Test: prehospital extended focused assessment sonography for trauma

Interventions

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

Also known as: eFAST

Negative or not performed prehospital eFAST; Positive prehospital eFAST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Usl di Bologna: lead

Study Sites (1)

Maggiore Hospital Ospedale Maggiore Carlo Alberto Pizzardi AUSL di Bologna

Bologna, 40110, Italy

Location

Related Publications (5)

• Botker MT, Jacobsen L, Rudolph SS, Knudsen L. The role of point of care ultrasound in prehospital critical care: a systematic review. Scand J Trauma Resusc Emerg Med. 2018 Jun 26;26(1):51. doi: 10.1186/s13049-018-0518-x.

  PMID: 29940990 BACKGROUND

• Chang R, Kerby JD, Kalkwarf KJ, Van Belle G, Fox EE, Cotton BA, Cohen MJ, Schreiber MA, Brasel K, Bulger EM, Inaba K, Rizoli S, Podbielski JM, Wade CE, Holcomb JB; PROPPR Study Group. Earlier time to hemostasis is associated with decreased mortality and rate of complications: Results from the Pragmatic Randomized Optimal Platelet and Plasma Ratio trial. J Trauma Acute Care Surg. 2019 Aug;87(2):342-349. doi: 10.1097/TA.0000000000002263.

  PMID: 31349348 BACKGROUND

• Clarke JR, Trooskin SZ, Doshi PJ, Greenwald L, Mode CJ. Time to laparotomy for intra-abdominal bleeding from trauma does affect survival for delays up to 90 minutes. J Trauma. 2002 Mar;52(3):420-5. doi: 10.1097/00005373-200203000-00002.

  PMID: 11901314 BACKGROUND

• El Zahran T, El Sayed MJ. Prehospital Ultrasound in Trauma: A Review of Current and Potential Future Clinical Applications. J Emerg Trauma Shock. 2018 Jan-Mar;11(1):4-9. doi: 10.4103/JETS.JETS_117_17.

  PMID: 29628662 BACKGROUND

• Jorgensen H, Jensen CH, Dirks J. Does prehospital ultrasound improve treatment of the trauma patient? A systematic review. Eur J Emerg Med. 2010 Oct;17(5):249-53. doi: 10.1097/MEJ.0b013e328336adce.

  PMID: 20124905 BACKGROUND

MeSH Terms

Conditions

Abdominal Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: June 25, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 26, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)