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

NCT ID: NCT04934384

Last Updated: 2021-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-25

Study Completion Date

2021-07-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma Splenic Trauma Abdomen Liver Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Positive prehospital eFAST

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

prehospital extended focused assessment sonography for trauma

Intervention Type DIAGNOSTIC_TEST

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

Negative or not performed prehospital eFAST

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

prehospital extended focused assessment sonography for trauma

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

prehospital extended focused assessment sonography for trauma

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

eFAST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Azienda Usl di Bologna

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maggiore Hospital Ospedale Maggiore Carlo Alberto Pizzardi AUSL di Bologna

Bologna, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29940990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31349348 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11901314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29628662 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20124905 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PreH-eFAST

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.