- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04333680
Transducer Selection in the Speed and Quality of Image Acquisition in FAST Exams
Study Overview
Status
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
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Speed and image quality of ultrasound exams performed with either transducer specified in the arms.
Other Names:
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ACTIVE_COMPARATOR: Curvilinear
Operators who will be using a curvilinear array-type transducer to perform the FAST exam on a healthy normal volunteer.
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Speed and image quality of ultrasound exams performed with either transducer specified in the arms.
Other Names:
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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
Sponsor
Investigators
- Principal Investigator: Sherwin A Soltani, MD, Baylor College of Medicine
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-46446
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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