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

Liver Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04934384
• Other study ID #: PreH-eFAST
• Status: Completed
• Start date: June 25, 2021
• Est. completion date: July 26, 2021

Study information

• Verified date: July 2021
• Source: Azienda Usl di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: July 26, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Liver Injury
• Trauma Abdomen
• Trauma Splenic
• Wounds and Injuries

Intervention

Diagnostic Test:
• prehospital extended focused assessment sonography for trauma
Sonographic procedure performed in the prehospital environment aiming at evaluating peritoneal free fluid in trauma patients

Locations

Country	Name	City	State
Italy	Maggiore Hospital Ospedale Maggiore Carlo Alberto Pizzardi AUSL di Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Usl di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Bøtker 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Jørgensen 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to definitive diagnostics or treatment	Time from the ED arrival to CT scan imaging or surgical intervention (whichever came first)	180 minutes
Secondary	Prehospital time	Time from EMS dispatch to ED arrival	240 minutes
Secondary	Sensitivity and specificity of prehospital eFAST	Sensitivity and specificity of prehospital eFAST calculated considering ED eFAST as the gold standard measure	240 minutes