- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bologna, Italy, 40110
- Maggiore Hospital Ospedale Maggiore Carlo Alberto Pizzardi AUSL di Bologna
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Positive prehospital eFAST
Patients with a positive prehospital eFAST, independently from their hemodynamic status or other vital signs
|
Sonographic procedure performed in the prehospital environment aiming at evaluating peritoneal free fluid in trauma patients
Other Names:
|
|
Negative or not performed prehospital eFAST
Patients with a positive prehospital eFAST, independently from their hemodynamic status or other vital signs
|
Sonographic procedure performed in the prehospital environment aiming at evaluating peritoneal free fluid in trauma patients
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
180 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prehospital time
Time Frame: 240 minutes
|
Time from EMS dispatch to ED arrival
|
240 minutes
|
|
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
|
240 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PreH-eFAST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trauma Abdomen
-
Children's Hospital of PhiladelphiaMayo ClinicRecruiting
-
Centre Hospitalier Departemental VendeeActive, not recruiting
-
University Hospital Plymouth NHS TrustNot yet recruitingTrauma Abdomen | Trauma (Including Fractures) | Trauma Centers | Trauma BluntUnited Kingdom
-
University of California, DavisEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingWounds and Injuries | Abdomen, Acute | Abdominal Injury | Blunt Trauma to Abdomen | Abdomen InjuryUnited States
-
Denver Health and Hospital AuthorityCompleted
-
New York Medical CollegeRecruitingIntestinal Obstruction | Trauma Abdomen | Intestinal PerforationUnited States
-
Tianjin Medical UniversityTianjin HospitalRecruitingAcute Abdomen | Abdominal Trauma | Emergency SurgeryChina
-
Assiut UniversityCompletedNon Enhanced MSCT Abdomen in Diagnosis of Acute AbdomenEgypt
-
KCI USA, IncCompleted
-
A.O. Ospedale Papa Giovanni XXIIIUnknown
Clinical Trials on prehospital extended focused assessment sonography for trauma
-
Baylor College of MedicineCompletedTrauma Injury | Diagnostic Abdominal UltrasonographyUnited States
-
University of California, DavisCompletedAbdominal InjuriesUnited States
-
Region StockholmEnrolling by invitationCardiovascular Diseases | Hypertension | Intracerebral Hemorrhage | Arterial Stiffness | TIA | Stroke, Acute Ischemic | Periferal Arterial Occlusive Disease, PAODSweden
-
Keller Fire RescueUnknownKidney Calculi | Pregnancy | Multiple Trauma | Ultrasonography | Aortic Aneurysm, Abdominal | Catheterization, VenousUnited States
-
Emory UniversityUnited States Department of DefenseCompletedAbdominal TraumaUnited States
-
University of California, DavisEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingWounds and Injuries | Abdomen, Acute | Abdominal Injury | Blunt Trauma to Abdomen | Abdomen InjuryUnited States
-
Rowan UniversityNational Institute of Mental Health (NIMH)Completed
-
Dartmouth-Hitchcock Medical CenterNational Institute of General Medical Sciences (NIGMS)RecruitingTrauma and Stressor Related Disorders | Autism Spectrum Disorder | Autism | Mental Health Services | PTSD and Trauma-related SymptomsUnited States
-
University Children's Hospital, ZurichOtto-Friedrich-University Bamberg; Catholic University of Eichstätt-IngolstadtRecruitingPost-traumatic Stress SymptomsSwitzerland
-
University of TalcaUniversidad del Desarrollo; Fondo Nacional de Desarrollo Científico y Tecnológico... and other collaboratorsRecruitingPost Traumatic Stress Disorder | Complex Post-Traumatic Stress DisorderChile