Vital Signs Patch: Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2015
End Date:June 2016
Contact:Leigh Ann Kelly
Email:lkelly@lifewatch.com
Phone:866-804-3634

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Vital Signs Patch: Early Feasibility and Usability Study - Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting

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:

- Arterial blood oxygen Saturation (SpO2)

- ECG (up to 3 - Lead)

- Heart Rate (Part of ECG)

- Surface Temperature

- Respiration

Inclusion Criteria:

- Adult male and female hospital in-patients

- Vital signs considered 'stable' by clinical caregivers

Exclusion Criteria:

- Pediatric patients

- Female patients who are pregnant

- Patients with internal or external defibrillators

- Patients who have undergone surgery and still have a fresh incision on the chest

- Patients with skin damage on the chest such as burns, irritation, infections, wounds,
etc.

- Patients who are in the Critical Care Unit (CCU)

- Patients who otherwise satisfy any of the contraindications associated with the VSP
system.
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Daniel J Cantillon, M.D
Phone: 330-888-4000
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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