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

LifeWatch Services

Status: Completed

Conditions: Automated Measurement of Vital Signs

Treatments: Device: Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration; Device: Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration

Study type: Interventional

Funder types: Industry

Identifiers

NCT02518100

VSP-F004

Details and patient eligibility

About

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.

Full 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

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

VSP 3-Lead Study Participants

Experimental group

Description:

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

Treatment:

Device: Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration

VSP 1-Lead Study Participants

Experimental group

Description:

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

Treatment:

Device: Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration