Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04202718
Recruitment Status : Withdrawn (Study never started due to COVID-19 pandemic)
First Posted : December 18, 2019
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Ashok Palagiri, Mercy Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arrythmia, Cardiac Diagnostic Test: VitalPatch Device Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04202718


Locations
Layout table for location information
United States, Missouri
Mercy Hospital Washington
Washington, Missouri, United States, 63090
Sponsors and Collaborators
Mercy Research
Layout table for additonal information
Responsible Party: Ashok Palagiri, Physician, Mercy Research
ClinicalTrials.gov Identifier: NCT04202718    
Other Study ID Numbers: 20-007
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020

Layout table for additional information
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
Keywords provided by Ashok Palagiri, Mercy Research:
ECG Interpretation
Additional relevant MeSH terms:
Layout table for MeSH terms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes