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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
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toSense, Inc. has developed a novel, non-invasive, body-worn sensor -CoVa Patch-that offers an alternative to invasive continuous cardiac output monitoring. To validate this new sensor's measurements of stroke volume and cardiac output, toSense, Inc. will conduct a study that compares its measurement performance to that from a pulmonary artery catheter using the thermodilution method.
This in an introductory clinical study with cardiac ICU patients featuring CoVa Patch. This is a single site, non-blinded, non-randomized study. It will employ a retrospective analysis comparing the accuracy of SV and CO. The 'test sensor', CoVa Patch, which will measure SV and CO quasi-continuously and non-invasively, approximately every 5-30 minutes for a period of time lasting approximately 12-48 hours. These measurements will be compared to those from a 'reference device', which is the pulmonary arterial catheter. It uses an invasive technique called thermodilution that will be made approximately every 4 hours. Measurements between the test and reference devices will be compared in a retrospective analysis once the study has completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men/Women who meet the inclusion/exclusion criteria |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cova Patch | Device | CoVa Patch will measure quasi-continuously, approximately every 5 minutes for a period between 6 to 48 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Stroke Volume | The primary objective of this study is to validate stroke volume (the amount of blood pumped by the left ventrical of the heart in one contraction) measurements made using CoVa Patch to those made using a pulmonary artery catheter and the thermodilution method. Thermodilution requires a pulmonary artery catheter and are calculated by a monitoring system based on temperature changes in the heart when a cooler solution is injected into the right atrium via the proximal port of a pulmonary artery catheter. | 4 Months |
| Accuracy of Cardiac Output | The secondary objective of this study is to validate cardiac output (the amount of blood the heart pumps per minute) measurements made using CoVa Patch to those made using a pulmonary artery catheter and the thermodilution method. Thermodilution requires a pulmonary artery catheter and are calculated by a monitoring system based on temperature changes in the heart when a cooler solution is injected into the right atrium via the proximal port of a pulmonary artery catheter. | 4 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Men and woman over the age of 18 years old.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac ICU | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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