VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection

Not Applicable

Withdrawn

• Conditions: Arrythmia, Cardiac
• Interventions: Diagnostic Test: VitalPatch Device

• Registration Number: NCT04202718
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-18
• Study Start: 2020-05-15
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-22
• Last Update Posted: 2020-06-24
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single group	VitalPatch Device	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.

Primary Outcome Measures

Name	Time	Method
Reduction in false alarms received from current telemetry monitoring technology	6 months	• Compare generation of false alarms with VitalPatch and current telemetry monitoring

Trial Locations

Locations (1)

Mercy Hospital Washington; 🇺🇸 Washington, Missouri, United States