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This feasibility study evaluates the use of the Vital Signs Patch (VSP) System to take and monitor specified vital signs. It will be used in parallel with the normal equipment the study site uses to take and monitor vital signs.
To assess the feasibility and usability of the total Vital Signs Patch (VSP) System in an actual hospital environment on in-patients by monitoring specified vital signs. The VSP System will be assessed for incorporation into the study site's Information Technology infrastructure. The VSP measurements will be compared with the predetermined expected results of the established vital signs equipment normally used by the facility based upon clinician protocols.
The VSP System can take and monitor patient vital signs in a more reliable and consistent manner by removing the human variability that occurs when clinicians manually take a patient's vital signs. The VSP has been designed to automatically take and monitor the following vital signs:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSP 3-Lead Study Participants | Experimental | Intervention: Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration The participants of this arm will have the following vital signs taken and recorded by the VSP System in the 3-lead (NEHB) configuration: Arterial blood oxygen Saturation (SpO2) ECG Heart Rate Surface Temperature Respiration |
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| VSP 1-Lead Study Participants | Experimental | Intervention: Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration. The participants of this arm will have the following vital signs taken and recorded by the VSP System in the 1-lead (PAL) configuration: Arterial blood oxygen Saturation (SpO2) ECG Heart Rate Surface Temperature Respiration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration | Device | Vital signs will be taken using the Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration on each study participant in each Arm of this study for comparison against the same vital signs taken with traditional methods used by the facility. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Outcome Measure - Successful Vital Signs Acquisition | Successful acquisition of Temperature, Heart Rate, ECG, Respiration, SpO2 daily for the inpatient stay of the subject up to four days. Success is achieved if all vital signs are obtained on a study participant. It is a composite result. | Up to Four Days |
| Measure | Description | Time Frame |
|---|---|---|
| Adhesion | Successful performance of the adhesive of the vital signs patch during use on subjects. Adhesion will be measured as either positive or negative for each subject. | Up to Four Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J Cantillon, M.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 6, 2018 | |
| Reset | Apr 2, 2018 |
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| Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration | Device | Vital signs will be taken using the Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration on each study participant in each Arm of this study for comparison against the same vital signs taken with traditional methods used by the facility. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 6, 2018 | Apr 2, 2018 |