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

NCT02518100 | Completed FDA Device

• 1 other identifier: VSP-F004
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Automated Measurement of Vital Signs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adhesion

  Up to Four Days

Study Arms (2)

VSP 3-Lead Study Participants

EXPERIMENTAL

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

VSP 1-Lead Study Participants

EXPERIMENTAL

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

Interventions

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

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.

VSP 3-Lead Study Participants

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

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.

VSP 1-Lead Study Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female hospital in-patients
• Vital signs considered 'stable' by clinical caregivers

You may not qualify if:

• 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.

Sponsors & Collaborators

• LifeWatch Services, Inc.: lead

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Daniel J Cantillon, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 7, 2015
• Study Start: September 22, 2015
• Primary Completion: August 16, 2016
• Study Completion: April 10, 2017
• Last Updated: April 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)