Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Arrhythmia
- Sponsor
- The Cleveland Clinic
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Connectivity
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients.
Detailed Description
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.
Investigators
Dan Cantillon
Principal Investigator
The Cleveland Clinic
Eligibility Criteria
Inclusion Criteria
- •\>= 18 years old and able to provide informed consent
- •Standard indication for cardiac telemetry monitoring (institutional standardized criteria) with valid electronic order
Exclusion Criteria
- •Cardiac implantable device (pacemaker or ICD)
- •Contact precautions or isolation
- •Telemetry discontinuation planned within 12 hours (i.e. anticipated discharge)
Outcomes
Primary Outcomes
Connectivity
Time Frame: 48 hours
Successful patch application by nursing, and transmission of cardiac waveform data to gateway and then to offline secure server
Continuity
Time Frame: 48 hours
Loss of cardiac waveform signal from patch compared with traditional telemetry monitor.
Secondary Outcomes
- Cardiac waveform (post hoc, offline)(48 hours)
- Agreement for cardiac arrhythmia detection (post hoc, offline)(48 hours)
- Body temperature (post hoc, offline)(48 hours)