Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY
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|ClinicalTrials.gov Identifier: NCT03480204|
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
|Condition or disease|
|Telemetry, Patch Monitor, Cardiac Arrhythmia, Alarm Fatigue|
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY|
|Actual Study Start Date :||March 19, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
- 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.
- 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.
- 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.
- 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.
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
|Contact: Daniel J Cantillon, MD||216 445-9220||Cantild@ccf.org|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Daniel J Cantillon, MD 216-445-9220 Cantild@ccf.org|
|Principal Investigator:||Daniel J Cantillon, MD||The Cleveland Clinic|