Cardiac ArrhythmiaNCT03480204
Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY
An observational study of Cardiac Arrhythmia, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 23 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-ICU hospitalized patients on the J8-3 nursing ward at the Cleveland Clinic Heart and Vascular Institute
Who may be able to join
- >= 18 years old and able to provide informed consent
- Standard indication for cardiac telemetry monitoring (institutional standardized criteria) with valid electronic order
Who cannot join
- Cardiac implantable device (pacemaker or ICD)
- Contact precautions or isolation
- Telemetry discontinuation planned within 12 hours (i.e. anticipated discharge)
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients.
Read the 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.
- Conditions
- Cardiac Arrhythmia
- Keywords
- Telemetry, Patch Monitor, Alarm Fatigue
- Medical subject headings
- Arrhythmias, Cardiac, Alert Fatigue, Health Personnel
What is being measured
The primary outcome is the main question the study is designed to answer.
Connectivity
Successful patch application by nursing, and transmission of cardiac waveform data to gateway and then to offline secure server
Measured: 48 hours
Continuity
Loss of cardiac waveform signal from patch compared with traditional telemetry monitor.
Measured: 48 hours
Secondary outcomes (3)
Agreement for cardiac arrhythmia detection (post hoc, offline)
Analysis of cardiac arrhythmia detections on patch compared with traditional telemetry for agreement, concordance and discordance.
Measured: 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.
Measured: 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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start19 Mar 2018
- Primary completion23 Dec 2018
- Study completion23 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Isansys Lifecare LTD
- Responsible party
- Principal investigator, Dan Cantillon, The Cleveland Clinic
- Investigators
- Daniel J Cantillon, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480204
- Sponsor's protocol ID
- 17-1656
- Status last verified
- Feb 2019
- First submitted
- 21 Mar 2018
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY
- ClinicalTrials.gov ID
- NCT03480204
- Acronym / sponsor ID
- 17-1656
- Conditions
- Cardiac Arrhythmia
- Keywords
- Telemetry, Patch Monitor, Alarm Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Isansys Lifecare LTD
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 23 Dec 2018 (actual)
- Study completion
- 23 Dec 2018 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-ICU hospitalized patients on the J8-3 nursing ward at the Cleveland Clinic Heart and Vascular Institute
Key inclusion criteria (2 listed)
- >= 18 years old and able to provide informed consent
- Standard indication for cardiac telemetry monitoring (institutional standardized criteria) with valid electronic order
Key exclusion criteria (3 listed)
- Cardiac implantable device (pacemaker or ICD)
- Contact precautions or isolation
- Telemetry discontinuation planned within 12 hours (i.e. anticipated discharge)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Connectivity
Time frame: 48 hours
Successful patch application by nursing, and transmission of cardiac waveform data to gateway and then to offline secure server
Continuity
Time frame: 48 hours
Loss of cardiac waveform signal from patch compared with traditional telemetry monitor.
3 secondary outcomes
Agreement for cardiac arrhythmia detection (post hoc, offline)
Time frame: 48 hours
Body temperature (post hoc, offline)
Time frame: 48 hours
Cardiac waveform (post hoc, offline)
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Cantillon, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Connectivity (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.