An interventional study of Portable, handheld point-of-care ultrasound device and Cart-based point-of-care ultrasound device in Image, Body, sponsored by Temple University. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Temple University · Not applicable, Interventional, and Diagnostic
Patients receiving a point-of-care ultrasound will be randomized into a portable, handheld device or a traditional cart-based ultrasound machine to compare diagnostic capability.
Patients who require a point-of-care ultrasound examination of their kidneys, gallbladder, heart, lung, or aorta will be enrolled. Once enrolled, the patient will be randomized to receive the point-of-care ultrasound using a portable, handheld ultrasound or a traditional cart based model. The ultrasound examinations will be performed by emergency medicine post-graduate year 1-3 residents or an ultrasound fellow and reviewed by the supervising emergency medicine attending physicians credentialed in performing and interpreting point-of-care ultrasound.
Based on the clinical presentation, the provider will perform one of the following ultrasounds: cardiac to assess ejection fraction ( \<50%, 30-50%, \<30%), lung to assess for presence or absence of B-lines, gallbladder to assess for the presence or absence of gallstones, renal to assess for the presence or absence of hydronephrosis, or aorta to assess for the presence or absence of an aneurysm. The diagnostic accuracy of the portable, handheld and the cart-based model will be assessed using the following as the diagnostic standard: cardiology-interpreted echocardiogram, radiology-interpreted ultrasound or computed tomography, or quality review of the point-of-care ultrasound by 3 ultrasound fellowship trained physicians.
Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive a point-of-care ultrasound using a handheld, portable ultrasound device.
Device: Portable, handheld point-of-care ultrasound device
Patients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine.
Device: Cart-based point-of-care ultrasound device
The patient will have an ultrasound performed using a handheld, portable device.
The patient will have an ultrasound performed using a traditional cart-based model.
Diagnostic Accuracy
The primary outcome will be difference in diagnostic accuracy between the two methods (the percent of diagnostic accuracy of the hand-held and the percent of diagnostic accuracy of the cart-based model).
Time frame: 1 day
Image Quality by Expert Review
Using a Likert scale of 1-7 (1 = unable to assess image; 7 = highest quality), ultrasound fellowship-trained providers will assess the image quality of images obtained by each provide in the study.
Time frame: 1 day
| Milestone | Portable, Handheld Device | Traditional, Cart-based Ultrasound |
|---|---|---|
| Started | 54 | 56 |
| Completed | 53 | 56 |
| Not completed | 1 | 0 |
The primary outcome will be difference in diagnostic accuracy between the two methods (the percent of diagnostic accuracy of the hand-held and the percent of diagnostic accuracy of the cart-based model).
| Participants | Portable, Handheld Device | Traditional, Cart-based Ultrasound |
|---|---|---|
| Diagnostic Accuracy | 53 | 56 |
Using a Likert scale of 1-7 (1 = unable to assess image; 7 = highest quality), ultrasound fellowship-trained providers will assess the image quality of images obtained by each provide in the study.
| score on a scale | Portable, Handheld Device | Traditional, Cart-based Ultrasound |
|---|---|---|
| Image Quality by Expert Review | 4 (1 to 7) | 5 (1 to 7) |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Portable, Handheld Device | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) |
| Traditional, Cart-based Ultrasound | 0/56 (0%) | 0/56 (0%) | 0/56 (0%) |
| Age, Continuous(years) | Portable, Handheld Device | Traditional, Cart-based Ultrasound | Total |
|---|---|---|---|
| Median | 60 (18 to 89) | 57 (18 to 90) | 59 (18 to 90) |
| Sex: Female, Male(Participants) | Portable, Handheld Device | Traditional, Cart-based Ultrasound | Total |
|---|---|---|---|
| Female | 27 | 34 | 61 |
| Male | 26 | 22 | 48 |
| Race and Ethnicity Not Collected(Participants) | Portable, Handheld Device | Traditional, Cart-based Ultrasound | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Portable, Handheld Device | Traditional, Cart-based Ultrasound | Total |
|---|---|---|---|
| United States | 53 | 56 | 109 |
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Plan to share: No
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