VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection

Study Overview
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Brief Summary
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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
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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.

Official Title
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VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection

Conditions
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Arrythmia, Cardiac

Intervention / Treatment
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* Diagnostic Test: VitalPatch Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG Interpretation