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Clinical Trials/NCT04202718
NCT04202718
Withdrawn
Not Applicable

VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection

Mercy Research1 site in 1 countryMay 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arrythmia, Cardiac
Sponsor
Mercy Research
Locations
1
Primary Endpoint
Reduction in false alarms received from current telemetry monitoring technology
Status
Withdrawn
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2020
End Date
November 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ashok Palagiri

Physician

Mercy Research

Eligibility 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

Outcomes

Primary Outcomes

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

Study Sites (1)

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