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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03480204

Enrollment

Registered

2018-03-29

Start date

2018-03-19

Completion date

2018-12-23

Last updated

2019-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmia

Keywords

Telemetry, Patch Monitor, Alarm Fatigue

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

United States

Outcome results