NCT03480204

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2018

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

March 21, 2018

Last Update Submit

February 15, 2019

Conditions

Cardiac Arrhythmia

Keywords

Telemetry, Patch Monitor, Alarm Fatigue

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Agreement for cardiac arrhythmia detection (post hoc, offline)

    48 hours

  • Body temperature (post hoc, offline)

    48 hours

  • Cardiac waveform (post hoc, offline)

    48 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \>= 18 years old and able to provide informed consent
  • Standard indication for cardiac telemetry monitoring (institutional standardized criteria) with valid electronic order

You may not qualify if:

  • Cardiac implantable device (pacemaker or ICD)
  • Contact precautions or isolation
  • Telemetry discontinuation planned within 12 hours (i.e. anticipated discharge)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Arrhythmias, CardiacAlert Fatigue, Health Personnel

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMental FatigueFatigueSigns and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Daniel J Cantillon, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2018

First Posted

March 29, 2018

Study Start

March 19, 2018

Primary Completion

December 23, 2018

Study Completion

December 23, 2018

Last Updated

February 19, 2019

Record last verified: 2019-02

Locations

US(1)