Clinical trial NCT04934384: The Role of Prehospital eFAST in Accelerating Time to Diagnostics or Definitive Treatment in the Emergency Department
Official title: The Role of Prehospital eFAST in Accelerating Time to Diagnostics or Definitive Treatment in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma Splenic
Trauma Abdomen
Liver Injury
Keywords: trauma
liver
spleen
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
First posted: 2021-06-22
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to definitive diagnostics or treatment
timeFrame: 180 minutes
Secondary outcomes:
measure: Prehospital time
timeFrame: 240 minutes
measure: Sensitivity and specificity of prehospital eFAST
timeFrame: 240 minutes
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Maggiore Hospital Ospedale Maggiore Carlo Alberto Pizzardi AUSL di Bologna
Study officials:
References:
citation: 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.
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.
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. doi: 10.1097/00005373-200203000-00002.
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.
citation: 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.