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

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

Study Overview

• Status: Completed
• Conditions: Cardiac Arrhythmia

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Non-ICU hospitalized patients on the J8-3 nursing ward at the Cleveland Clinic Heart and Vascular Institute

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Isansys Lifecare LTD

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2018
• Primary Completion (Actual): December 23, 2018
• Study Completion (Actual): December 23, 2018

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 15, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Telemetry, Patch Monitor, Alarm Fatigue
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 17-1656

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No