NCT00654693已完成不适用
A Pilot Study to Evaluate the Performance of Nihon Kohden's NTX Wireless Patient Monitoring System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Evaluation of patient compliance with wearing device
研究概览
简要总结
- Determine the accuracy of the NTX wireless monitoring system alerts
- Evaluate patient compliance with wearing device
- Determine false alarm rates
详细描述
Approximately 150 patients will have wireless monitors attached to their arm. They will have their vital signs filtered through software that generates alerts and records data. The alert engine will produce pager and application based pop-up alerts which will be sent to the research nurse. Low and high limit alarms will be set according to the published guidelines (Hillman, K. et. Al., Resuscitation 48(2): 105-10, 2001) and adjusted at will by the response team.
During this portion of the study, the following research related procedures will be performed:
- begin continuous vital signs monitoring (BP - 1x per hour, 3 lead ECG -continuous, HR - continuous, SpO2 - continuous)
- PI or Co-PI will review each alert that's generated. The clinical significance will be determined and recorded in the study database
- Record patient's signs and symptoms daily
- Assess concomitant
- Assess AE's, SAEs
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
- •Ability to give written informed consent
- •Patients that are hospitalized for longer than 24 hours and are located on the 4th, 5th, or 6th floor of the Vanderbilt University Medical Center Round Wing
- •Patients must be ≥18 years of age
排除标准
- •ICU patients
- •Female subjects who are pregnant
- •Patients < 18 years of age
- •Patients that have a contradiction for continuous Blood Pressure monitoring
结局指标
主要结局
Evaluation of patient compliance with wearing device
时间窗: 24 hour minimum post op
次要结局
- Determine accuracy of the NTX wireless monitoring system(duration of patient involvement)
- Determine false alarm rates(duration of patient involvement)
研究者
James Berry
Professor
Vanderbilt University
研究点 (1)
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