Transducer Selection in the Speed and Quality of Image Acquisition in FAST Exams

March 2, 2022 updated by: Sherwin Soltani, Baylor College of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. In performing this exam, time to acquisition of adequate images is crucial to clinical decision-making as patients undergoing this exam have a high probability of deteriorating if not intervened on appropriately.

Low-frequency ultrasound is used to image the abdominal cavity and pericardium in these patients, using either a curvilinear transducer or a phased-array transducer. Both of these transducers are capable of acquiring the images necessary to interpret a FAST exam, but it has not been well studied whether using one transducer instead of the other improves time to image acquisition or image quality.

In this study, physician ultrasound operators are asked to perform FAST exams on healthy non-injured volunteers for the purpose of determining if there is a difference in the time to acquisition or quality of images between phased-array and curvilinear transducers.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Phased Array
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
Speed and image quality of ultrasound exams performed with either transducer specified in the arms.
Other Names:
  • FAST exam
  • Abdominal sonography
  • Abdominal ultrasonography
ACTIVE_COMPARATOR: Curvilinear
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
Speed and image quality of ultrasound exams performed with either transducer specified in the arms.
Other Names:
  • FAST exam
  • Abdominal sonography
  • Abdominal ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Required
Time Frame: Assessed and reported at study completion, estimated 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image Quality
Time Frame: Assessed and reported at study completion, estimated 1 year
Quality of the images, based on retrospectively reviewing and assessing the interpretability of sonographic images taken during the FAST exam performed with either transducer. These images are captured during the performance of the ultrasound exam.
Assessed and reported at study completion, estimated 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Sherwin A Soltani, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 27, 2021

Primary Completion (ACTUAL)

June 3, 2021

Study Completion (ACTUAL)

June 3, 2021

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (ACTUAL)

April 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-46446

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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.

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