NCT02521922

Vital Signs Patch Early Feasibility and Usability Study

Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: LifeWatch Services, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To assess the feasibility and usability of the VSP System in the in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and console. The VSP System will be incorporated into the study site's Information Technology infrastructure.

Detailed description

The primary objective of this clinical feasibility study is to evaluate the feasibility of the Vital Signs Patch System (VSP). The VSP will be incorporated into the study site's Information Technology infrastructure and worn by in-patients for a minimum of 3 days and for the duration of their hospital stay up to 7 days. The VSP will take and monitor vital signs in addition to the normal equipment the facility uses to monitor and take vital signs. This study will not be assessing safety and no comparator groups will be used. As this study will not be treating any particular disease or condition, no randomization or blinding is required. Subjects will be chosen as they are admitted in accordance with the general population characteristics, inclusion and exclusion criteria and willingness to sign the Informed Consent. This clinical study involves a device with no additional drugs administered. During this study, a single VSP System patch will be worn for up to 48 hours. The first patch will be placed using the NEHB configuration. After the first 48 hours, the NEHB-configured patch will be replaced with a new patch in the PAL configuration. The second patch can remain on the subject for the duration of the subject's hospital stay, or up to seven (7) consecutive days. Individual patient use will determine the duration of time that the second patch can be worn.

Conditions

• Vital Signs

Interventions

Type	Name	Description
DEVICE	VSP System - NEHB Configuration	VSP System - NEHB Configuration will take and record participant vital signs. NEHB is the last name of the physician who developed the configuration. It is not an acronym.
DEVICE	VSP System - PAL Configuration	VSP System - PAL Configuration will take and record patient vital signs. PAL is the name created by the engineering team of this device. It is not an acronym.

Timeline

• Start date: 2014-04-16
• Primary completion: 2016-06-09
• Completion: 2017-04-01
• First posted: 2015-08-13
• Last updated: 2017-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study