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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Portable, Handheld Device | Experimental | Patients will receive a point-of-care ultrasound using a handheld, portable ultrasound device. |
|
| Traditional, Cart-based Ultrasound | Active Comparator | Patients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portable, handheld point-of-care ultrasound device | Device | The patient will have an ultrasound performed using a handheld, portable device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
1. English and Spanish-speaking patients, who require a gallbladder, cardiac, renal, aorta, or lung ultrasound based on the discretion of the treating physician.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lewis Katz School of Medicine at Temple University | Philadelphia | Pennsylvania | 19140 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Portable, Handheld Device | Patients will receive a point-of-care ultrasound using a handheld, portable ultrasound device. Portable, handheld point-of-care ultrasound device: The patient will have an ultrasound performed using a handheld, portable device. |
| FG001 | Traditional, Cart-based Ultrasound | Patients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine. Cart-based point-of-care ultrasound device: The patient will have an ultrasound performed using a traditional cart-based model. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Portable, Handheld Device | Patients will receive a point-of-care ultrasound using a handheld, portable ultrasound device. Portable, handheld point-of-care ultrasound device: The patient will have an ultrasound performed using a handheld, portable device. |
| BG001 | Traditional, Cart-based Ultrasound |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | 1 day |
|
1 day
There is no risk associated with point-of-care ultrasound.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Portable, Handheld Device | Patients will receive a point-of-care ultrasound using a handheld, portable ultrasound device. Portable, handheld point-of-care ultrasound device: The patient will have an ultrasound performed using a handheld, portable device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Gibbons | Temple University Hospital | 2157075522 | ryan.gibbons@tuhs.temple.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2023 | Sep 3, 2023 | Prot_SAP_000.pdf |
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| Cart-based point-of-care ultrasound device | Device | The patient will have an ultrasound performed using a traditional cart-based model. |
|
Patients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine. Cart-based point-of-care ultrasound device: The patient will have an ultrasound performed using a traditional cart-based model. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 1 day |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Traditional, Cart-based Ultrasound | Patients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine. Cart-based point-of-care ultrasound device: The patient will have an ultrasound performed using a traditional cart-based model. | 0 | 56 | 0 | 56 | 0 | 56 |
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