Back to resultsVitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection
Primary Purpose
Arrythmia, Cardiac
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VitalPatch Device
Sponsored by
About this trial
This is an interventional supportive care trial for Arrythmia, Cardiac focused on measuring ECG Interpretation
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
Sites / Locations
- Mercy Hospital Washington
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single group
Arm 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.
Outcomes
Primary Outcome Measures
Reduction in false alarms received from current telemetry monitoring technology
• Compare generation of false alarms with VitalPatch and current telemetry monitoring
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04202718
Brief Title
VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection
Official Title
VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study never started due to COVID-19 pandemic
Study Start Date
May 15, 2020 (Anticipated)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercy Research
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrythmia, Cardiac
Keywords
ECG Interpretation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single group
Arm Type
Other
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
VitalPatch Device
Intervention Description
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 Measure Information:
Title
Reduction in false alarms received from current telemetry monitoring technology
Description
• Compare generation of false alarms with VitalPatch and current telemetry monitoring
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Mercy Hospital Washington
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
12. IPD Sharing Statement
Learn more about this trial
VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection
We'll reach out to this number within 24 hrs