Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY

Completed

• Conditions: Cardiac Arrhythmia

• Registration Number: NCT03480204
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2018-03-19
• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-29
• Primary Completion: 2018-12-23
• Study Completion: 2018-12-23
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-15
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Connectivity	48 hours	Successful patch application by nursing, and transmission of cardiac waveform data to gateway and then to offline secure server
Continuity	48 hours	Loss of cardiac waveform signal from patch compared with traditional telemetry monitor.

Secondary Outcome Measures

Name	Time	Method
Cardiac waveform (post hoc, offline)	48 hours	Pre-specified analysis of cardiac waveform characteristics in association with pre-specified clinical events such as deployment of emergency response team.
Agreement for cardiac arrhythmia detection (post hoc, offline)	48 hours	Analysis of cardiac arrhythmia detections on patch compared with traditional telemetry for agreement, concordance and discordance.
Body temperature (post hoc, offline)	48 hours	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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States