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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04333680
Enrollment
31
Registered
2020-04-03
Start date
2021-02-27
Completion date
2021-06-03
Last updated
2022-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostic Abdominal Ultrasonography, Trauma Injury

Keywords

ultrasonography, FAST exam, Focused assessment of sonography for trauma, Transducer selection

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.

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.

Interventions

DIAGNOSTIC_TESTFocused Assessment of Sonography for Trauma Exam

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

Sponsors

Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Time RequiredAssessed and reported at study completion, estimated 1 yearTotal 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.

Secondary

MeasureTime frameDescription
Image QualityAssessed and reported at study completion, estimated 1 yearQuality 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026