The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality. The Zio® monitor (Study Device) is an adhesive patch that is worn on the upper left chest for a specified period of time and is similar to a band aid. The Study Device contains a battery-powered heart monitor and will look at the heart rhythm and rate.
This is a prospective single-arm study to demonstrate adequate analyzable time for use in pediatric patients up to 14 days of device wear. The study will incorporate a simplified skin preparation procedure. The objective is to evaluate analyzable time of the Zio® monitor device over the wear duration (up to 14 days) in a population 1 to 17 years of age. The study will incorporate a simplified skin preparation procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
36
Evaluate analyzable time of the Zio monitor over the wear duration of up to 14 days in a pediatric population.
Children's National Hospital
Washington D.C., District of Columbia, United States
NOT_YET_RECRUITINGSt. Luke's Children's Hospital
Boise, Idaho, United States
RECRUITINGBoston Children's Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGWashU Medicine
St Louis, Missouri, United States
NOT_YET_RECRUITINGPerformance Objective
The duration of non-artifact ECG signal as a proportion of the device total wear time will be assessed. The sample proportion with analyzable time \>80% is assumed to be 90%. The performance objective will be met if the lower bound of the 95% confidence interval is at least 75%. Percent analyzable time is defined as the duration of non-artifact ECG signal as a proportion of the device total wear time.
Time frame: Up to 14 days
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