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

The Cleveland Clinic25 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cardiac Arrhythmia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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