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OpenTrials
Completed

NCT Number: NCT03480204

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.

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Key information

Conditions

Cardiac Arrhythmia Alert Fatigue, Health Personnel Arrhythmias, Cardiac Behavior Behavioral Symptoms Cardiovascular Diseases Fatigue Heart Diseases Mental Fatigue Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Connectivity

    Time frame: 48 hours

    Successful patch application by nursing, and transmission of cardiac waveform data to gateway and then to offline secure server

  2. Continuity

    Time frame: 48 hours

    Loss of cardiac waveform signal from patch compared with traditional telemetry monitor.

Secondary outcomes

  1. Agreement for cardiac arrhythmia detection (post hoc, offline)

    Time frame: 48 hours

    Analysis of cardiac arrhythmia detections on patch compared with traditional telemetry for agreement, concordance and discordance.

  2. Body temperature (post hoc, offline)

    Time frame: 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.

  3. Cardiac waveform (post hoc, offline)

    Time frame: 48 hours

    Pre-specified analysis of cardiac waveform characteristics in association with pre-specified clinical events such as deployment of emergency response team.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Isansys Lifecare LTD

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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