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

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ClinicalTrials.gov Identifier: NCT03480204
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Isansys Lifecare LTD
Information provided by (Responsible Party):
Dan Cantillon, The Cleveland Clinic

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

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY
Actual Study Start Date : March 19, 2018
Actual Primary Completion Date : December 23, 2018
Actual Study Completion Date : December 23, 2018
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480204


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Isansys Lifecare LTD
Investigators
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Principal Investigator: Daniel J Cantillon, MD The Cleveland Clinic
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Dan Cantillon, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03480204    
Other Study ID Numbers: 17-1656
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dan Cantillon, The Cleveland Clinic:
Telemetry, Patch Monitor, Alarm Fatigue
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes