VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection

Mercy Research

Status: Withdrawn

Conditions: Arrythmia, Cardiac

Treatments: Diagnostic Test: VitalPatch Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04202718

20-007

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Single group

Other group

Description:

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.

Treatment:

Diagnostic Test: VitalPatch Device