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Completed

NCT Number: NCT02521922

Vital Signs Patch Early Feasibility and Usability Study

To assess the feasibility and usability of the VSP System in the in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and console. The VSP System will be incorporated into the study site's Information Technology infrastructure.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mt. Sinai Medical Center

New York, 10029, United States

About this study

The primary objective of this clinical feasibility study is to evaluate the feasibility of the Vital Signs Patch System (VSP). The VSP will be incorporated into the study site's Information Technology infrastructure and worn by in-patients for a minimum of 3 days and for the duration of their hospital stay up to 7 days.

The VSP will take and monitor vital signs in addition to the normal equipment the facility uses to monitor and take vital signs. This study will not be assessing safety and no comparator groups will be used. As this study will not be treating any particular disease or condition, no randomization or blinding is required. Subjects will be chosen as they are admitted in accordance with the general population characteristics, inclusion and exclusion criteria and willingness to sign the Informed Consent.

This clinical study involves a device with no additional drugs administered.

During this study, a single VSP System patch will be worn for up to 48 hours. The first patch will be placed using the NEHB configuration. After the first 48 hours, the NEHB-configured patch will be replaced with a new patch in the PAL configuration. The second patch can remain on the subject for the duration of the subject's hospital stay, or up to seven (7) consecutive days. Individual patient use will determine the duration of time that the second patch can be worn.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult male and female in-patients with 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 in the Critical Care Unit (CCU)
  • Patients who otherwise satisfy any of the contraindications associated with the VSP system.

Treatment and study plan

VSP System - NEHB Configuration

Device

VSP System - NEHB Configuration will take and record participant vital signs. NEHB is the last name of the physician who developed the configuration. It is not an acronym.

VSP System - PAL Configuration

Device

VSP System - PAL Configuration will take and record patient vital signs. PAL is the name created by the engineering team of this device. It is not an acronym.

Primary outcomes

  1. Composite Outcome Measure - 100% Successful Vital Signs Acquisition

    Time frame: Up to seven days

    Successful acquisition of Temperature, Heart Rate, ECG, Respiration, and SpO2 daily for the inpatient stay of the subject up to seven days. Success is achieved if all vital signs are obtained on a study participant. It is a composite result.

Secondary outcomes

  1. Composite Outcome Measure - Adhesive Performance - Measurement of skin irritation resulting from adhesive used with electrodes.

    Time frame: Up to seven days

    Successful performance of the adhesive of the patch throughout the study for each subject. Subject skin will be checked daily to determine if irritation has resulted where the electrodes have been placed. The results will be either positive or negative for skin irritation. This is a composite outcome measure.

Sponsors and collaborators

Lead sponsor

LifeWatch Services, Inc.

Industry

Registry information

Official study title

Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting

Acronym: VSP

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Aug 13, 2015
Registry last updated
Apr 4, 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.

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