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Technology was approved by FDA before study enrolled subjects
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| Name | Class |
|---|---|
| Caption Health, Inc. | INDUSTRY |
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Participants scheduled for for an echocardiogram (echo) and being evaluated for, or is positive for COVID-19 will be asked if they would be willing to have their echo done using a new software program on one of the hand-held ultrasound scanners.
The new software program guides the investigator, or any other non-sonographer, to take the best possible pictures of the participants heart. The prior version of this software is already being used clinically and is FDA approved. The main reason for using the updated version is that it's faster and better in terms of guiding the user.
To enable healthcare professionals that are not proficient in transthoracic echo (TTE) to acquire images in patients being evaluated for or positive for COVID-19. By leveraging the capabilities of the Caption AI which is designed to train novice users on how to acquire TTE, this would minimize the risk of sonographers to be exposed to COVID-19. Additionally, minimizing sonographer interaction with patients being evaluated for or positive for COVID 19 minimizes the risk of sonographers as vectors for transmission to other patients. Lastly, since the Caption AI device will be dedicated to the COVID wards and COVID ICU and not transported to other locations, use of the CAPTION AI device will help to limit viral transmission via the surfaces of the ultrasound machine. These images will be assessed by qualified medical professionals for diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Echocardiogram patients | Experimental | Patients scheduled to have an echocardiogram (echo) and who are also being evaluated for, or are positive for COVID-19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caption AI | Device | Software program that guides the investigator or any other non-sonographer to take the best possible pictures of the heart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patient echos that are not interpretable | Images obtained through the point of care AI machine will be uploaded to the cardiology PACS system and read. If the images are felt to be not interpretable, the echo lab will send a sonographer with a regular echo machine to the patient's room to perform the study. | Up to 1 hour |
| Percent of patient echos that provide an automated (AI) LVEF (left ventricular ejection fraction) | There need to be enough images taken of sufficient quality to allow for calculation of an automated LVEF by the AI algorithm | Up to 1 hour |
| Time to acquire images as measured by time stamps | up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of agreement between AI calculate LVEF and LVEF read by physician | Up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sreekanth Vemulapallli, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Health | Durham | North Carolina | 27710 | United States | ||
| Duke University Medical Center |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Durham |
| North Carolina |
| 27710 |
| United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |