NCT04333680

Brief Summary

The Focused Assessment of Sonography for Trauma (FAST) is a rapid point-of-care ultrasound exam performed on blunt and penetrating trauma patients who are too critically injured to be transported to a CT scanner. Low-frequency ultrasound is used to image the abdomen and pericardium in these patients, using either a curvilinear transducer or a phased-array transducer. Whether the use of one transducer or the other is better for this application is not well studied. In this study, physician ultrasound operators will perform the FAST exam on healthy non-injured volunteers to determine if the speed or quality of images between the two transducer types is different.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

February 27, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2021

Completed
Last Updated

March 3, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

March 11, 2020

Last Update Submit

March 2, 2022

Conditions

Diagnostic Abdominal UltrasonographyTrauma Injury

Keywords

ultrasonographyFAST examFocused assessment of sonography for traumaTransducer selection

Outcome Measures

Primary Outcomes (1)

  • Time Required

    Total time necessary to perform a FAST ultrasound examination using either transducer specified, starting from when the exam is begun to when the last view is completed by the ultrasound operator. The average exam is estimated to take no more than 10 minutes to complete.

    Assessed and reported at study completion, estimated 1 year

Secondary Outcomes (1)

  • Image Quality

    Assessed and reported at study completion, estimated 1 year

Study Arms (2)

Phased Array

ACTIVE COMPARATOR

Operators who will be using a phased array-type transducer to perform the FAST exam on a healthy normal volunteer.

Diagnostic Test: Focused Assessment of Sonography for Trauma Exam

Curvilinear

ACTIVE COMPARATOR

Operators who will be using a curvilinear array-type transducer to perform the FAST exam on a healthy normal volunteer.

Diagnostic Test: Focused Assessment of Sonography for Trauma Exam

Interventions

Focused Assessment of Sonography for Trauma ExamDIAGNOSTIC_TEST

Speed and image quality of ultrasound exams performed with either transducer specified in the arms.

Also known as: FAST exam, Abdominal sonography, Abdominal ultrasonography
CurvilinearPhased Array

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Study's ultrasound operators must be emergency medicine residents or PA/NP fellows currently enrolled in an emergency medicine training program between the ages of 18 - 64 years who are not pregnant.
  • Study's healthy normal volunteers must be emergency medicine faculty, fellows, or PA/NPs aged 18-64 with no anatomic abnormalities, prior surgeries, or significant chronic medical conditions.

You may not qualify if:

  • Pregnant women
  • Prisoners
  • Anyone below the age of 18 or above the age of 64 years old
  • Individuals with abnormal/thoracic anatomy (such as individuals with situs inversus) and individuals with chronic medical conditions that would limit their ability to participate in the study or have ultrasound images taken of them.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Accidental Injuries

Interventions

Focused Assessment with Sonography for Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisPoint-of-Care TestingPoint-of-Care SystemsPatient Care ManagementHealth Services Administration

Study Officials

  • Sherwin A Soltani, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 11, 2020

First Posted

April 3, 2020

Study Start

February 27, 2021

Primary Completion

June 3, 2021

Study Completion

June 3, 2021

Last Updated

March 3, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

No IPD will be shared.

Locations

US(1)