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

Cardiac Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480204
• Other study ID #: 17-1656
• Status: Completed
• Start date: March 19, 2018
• Est. completion date: December 23, 2018

Study information

• Verified date: February 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 23, 2018
• Est. primary completion date: December 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Isansys Lifecare LTD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Connectivity	Successful patch application by nursing, and transmission of cardiac waveform data to gateway and then to offline secure server	48 hours
Primary	Continuity	Loss of cardiac waveform signal from patch compared with traditional telemetry monitor.	48 hours
Secondary	Agreement for cardiac arrhythmia detection (post hoc, offline)	Analysis of cardiac arrhythmia detections on patch compared with traditional telemetry for agreement, concordance and discordance.	48 hours
Secondary	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.	48 hours
Secondary	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.	48 hours