An observational study in Cardiac Arrhythmia, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-19.
Sponsored by The Cleveland Clinic · Observational
This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients.
This study evaluates the feasibility and usability of a wearable patch cardiac monitor, gateway and server concomitant with standard-of-care cardiac telemetry monitoring for non-ICU hospitalized patients on a selected nursing ward at the Cleveland Clinic Heart and Vascular Institute. All patients will receive routine clinical care on the basis of the traditional telemetry monitoring using the usual processes. The patch monitor data will not be reviewed in real-time, and only analyzed post hoc for agreement with the standard-of-care.
Non-ICU hospitalized patients on the J8-3 nursing ward at the Cleveland Clinic Heart and Vascular Institute
Exclusion Criteria:
Connectivity
Successful patch application by nursing, and transmission of cardiac waveform data to gateway and then to offline secure server
Time frame: 48 hours
Continuity
Loss of cardiac waveform signal from patch compared with traditional telemetry monitor.
Time frame: 48 hours
Agreement for cardiac arrhythmia detection (post hoc, offline)
Analysis of cardiac arrhythmia detections on patch compared with traditional telemetry for agreement, concordance and discordance.
Time frame: 48 hours
Body temperature (post hoc, offline)
Body temperature recorded by patch compared with nursing documentation in a post hoc analysis. Data from patch will not be assessed for patient care in real time.
Time frame: 48 hours
Cardiac waveform (post hoc, offline)
Pre-specified analysis of cardiac waveform characteristics in association with pre-specified clinical events such as deployment of emergency response team.
Time frame: 48 hours
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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