NCT02518100

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

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: 32 (actual)
• Sponsor: LifeWatch Services, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Automated Measurement of Vital Signs

Interventions

Type	Name	Description
DEVICE	Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration	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.
DEVICE	Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration	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.

Timeline

• Start date: 2015-09-22
• Primary completion: 2016-08-16
• Completion: 2017-04-10
• First posted: 2015-08-07
• Last updated: 2017-04-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study