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OpenTrials
Completed

NCT Number: NCT02518100

Vital Signs Patch: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Composite Outcome Measure - Successful Vital Signs Acquisition

    Time frame: Up to Four Days

    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.

Secondary outcomes

  1. Adhesion

    Time frame: Up to Four Days

    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.

Sponsors and collaborators

Lead sponsor

LifeWatch Services, Inc.

Industry

Registry information

Official study title

Vital Signs Patch: Early Feasibility and Usability Study - Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting

Acronym: VSP

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Aug 7, 2015
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.