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

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.

Study Overview

• Status: Completed
• Conditions: Automated Measurement of Vital Signs
• Intervention / Treatment: Device: Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration; Device: Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VSP 3-Lead Study Participants; 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	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.
Experimental: VSP 1-Lead Study Participants; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: LifeWatch Services, Inc.
• Investigators: Principal Investigator: Daniel J Cantillon, M.D., The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2015
• Primary Completion (Actual): August 16, 2016
• Study Completion (Actual): April 10, 2017

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: VSP-F004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes