VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection

June 22, 2020 updated by: Ashok Palagiri, Mercy Research
Subjects in this study will wear the VitalPatch with the added ECG Interpretation and arrhythmia detection features which will expedite the identification of patients whose condition may rapidly deteriorate as well as eliminate the majority of non-actionable alarms.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This project intends to validate, through comparative study, the output of new technologies (ECG Interpretation and arrhythmia detection) to the VistaCenter platform, aiming to replace current telemetry monitoring equipment. The new technology, through the previous Mercy pilot study, has demonstrated greater accuracy in the detection of ventricular tachycardia patterns and other dysrhythmias/arrhythmias, as well as, reducing the volume of false alarms resulting in the mitigation of alarm fatigue experienced by bedside staff and monitor technicians.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Washington, Missouri, United States, 63090
        • Mercy Hospital Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years old,
  • No skin trauma to the site where the patch will be applied
  • No known allergies to hydrocolloid or silicone based adhesives
  • Admitted to Mercy Hospital Washington Cardiac Unit on the 5th floor and have been placed in one of the assigned rooms and require cardiac/telemetry monitoring as ordered by their physician

Exclusion Criteria:

  • Pacemaker or Implanted Defibrillator (ICD)
  • Pregnancy
  • Adults unable to provide informed consent
  • Individuals who cannot read and understand English
  • Prisoners
  • Not recommended for use in MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Single group
Where a wearable biosensor is being considered for use in the health management of individuals at high-risk for poor health outcomes, and in the detection or prevention of adverse events within settings where traditional monitoring devices are not currently in use, the ECG interpretation will provide Arrhythmia detection which will help ensure that irregular rhythms will be reported quickly.
Diagnostic test: VitalPatch Device
The VitalPatch® is an IRB (791130) and FDA approved wearable device that allows for the constant monitoring of biometric measurements and may have utility in the health management of individuals at high-risk for poor health outcomes and in the detection or prevention of adverse events within settings where more traditional telemetry monitoring devices are not currently in use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in false alarms received from current telemetry monitoring technology
Time Frame: 6 months
• Compare generation of false alarms with VitalPatch and current telemetry monitoring
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercy Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 15, 2020

Primary Completion (ANTICIPATED)

November 30, 2020

Study Completion (ANTICIPATED)

November 30, 2020

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (ACTUAL)

December 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 22, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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