Clinical trial NCT04333680: Transducer Selection in the Speed and Quality of Image Acquisition in FAST Exams
Official title: Transducer Selection in the Speed and Quality of Image Acquisition in FAST Exams
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diagnostic Abdominal Ultrasonography
Trauma Injury
Keywords: ultrasonography
FAST exam
Focused assessment of sonography for trauma
Transducer selection
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time Required
timeFrame: Assessed and reported at study completion, estimated 1 year
Secondary outcomes:
measure: Image Quality
timeFrame: Assessed and reported at study completion, estimated 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Sherwin A Soltani, MD
role: PRINCIPAL_INVESTIGATOR
References: