NCT04333680

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diagnostic Abdominal Ultrasonography
• Trauma Injury

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Focused Assessment of Sonography for Trauma Exam	Speed and image quality of ultrasound exams performed with either transducer specified in the arms.

Timeline

• Start date: 2021-02-27
• Primary completion: 2021-06-03
• Completion: 2021-06-03
• First posted: 2020-04-03
• Last updated: 2022-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study