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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diagnostic Abdominal Ultrasonography, Trauma Injury

Intervention / Treatment
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* Diagnostic Test: Focused Assessment of Sonography for Trauma Exam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phased Array<br>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<br>* Speed and image quality of ultrasound exams performed with either transducer specified in the arms.<br>* Other names: Abdominal ultrasonography;|
| Active Comparator: Curvilinear<br>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<br>* Speed and image quality of ultrasound exams performed with either transducer specified in the arms.<br>* Other names: Abdominal ultrasonography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasonography, FAST exam, Focused assessment of sonography for trauma, Transducer selection