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| Name | Class |
|---|---|
| Isansys Lifecare LTD | UNKNOWN |
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This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients.
This study evaluates the feasibility and usability of a wearable patch cardiac monitor, gateway and server concomitant with standard-of-care cardiac telemetry monitoring for non-ICU hospitalized patients on a selected nursing ward at the Cleveland Clinic Heart and Vascular Institute. All patients will receive routine clinical care on the basis of the traditional telemetry monitoring using the usual processes. The patch monitor data will not be reviewed in real-time, and only analyzed post hoc for agreement with the standard-of-care.
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| Measure | Description | Time Frame |
|---|---|---|
| Connectivity | Successful patch application by nursing, and transmission of cardiac waveform data to gateway and then to offline secure server | 48 hours |
| Continuity | Loss of cardiac waveform signal from patch compared with traditional telemetry monitor. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement for cardiac arrhythmia detection (post hoc, offline) | Analysis of cardiac arrhythmia detections on patch compared with traditional telemetry for agreement, concordance and discordance. | 48 hours |
| Body temperature (post hoc, offline) |
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Inclusion Criteria:
Exclusion Criteria:
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Non-ICU hospitalized patients on the J8-3 nursing ward at the Cleveland Clinic Heart and Vascular Institute
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J Cantillon, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D000071064 | Alert Fatigue, Health Personnel |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Body temperature recorded by patch compared with nursing documentation in a post hoc analysis. Data from patch will not be assessed for patient care in real time.
| 48 hours |
| Cardiac waveform (post hoc, offline) | Pre-specified analysis of cardiac waveform characteristics in association with pre-specified clinical events such as deployment of emergency response team. | 48 hours |
| D005222 | Mental Fatigue |
| D005221 | Fatigue |
| D012816 | Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |