Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Connectivity
研究概览
简要总结
This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 18 years old and able to provide informed consent
- •Standard indication for cardiac telemetry monitoring (institutional standardized criteria) with valid electronic order
排除标准
- •Cardiac implantable device (pacemaker or ICD)
- •Contact precautions or isolation
- •Telemetry discontinuation planned within 12 hours (i.e. anticipated discharge)
结局指标
主要结局
Connectivity
时间窗: 48 hours
Successful patch application by nursing, and transmission of cardiac waveform data to gateway and then to offline secure server
Continuity
时间窗: 48 hours
Loss of cardiac waveform signal from patch compared with traditional telemetry monitor.
次要结局
- Cardiac waveform (post hoc, offline)(48 hours)
- Agreement for cardiac arrhythmia detection (post hoc, offline)(48 hours)
- Body temperature (post hoc, offline)(48 hours)
研究者
Dan Cantillon
Principal Investigator
The Cleveland Clinic