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临床试验/NCT02075398
NCT02075398已完成不适用

Evaluation of Respiration Rate Parameters During Motion in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

Medtronic - MITG1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
To determine the respiration rate performance in healthy adult volunteers during motion when compared to established technologies for measuring parameters related to respiration.

研究概览

简要总结

To validate the Respiration Rate Version 2.0 algorithm, housed in the Nellcor Bedside Respiratory Patient Monitoring System, for performance during motion conditions.

研究设计

研究类型
Observational
观察模型
Case Only

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or Female subjects 18 years or older (inclusive)
  • Subject is able to participate for the duration of the study
  • Subject is willing to sign an informed consent

排除标准

  • Subject with abnormalities that may prevent proper application of the devices
  • Physiologic abnormalities that prevent proper application of pulse oximetry sensor
  • Severe contact allergies that cause a reaction to standard adhesive materials such as those fund in medical sensors and electrodes
  • Subjects with significant arrhythmia, as determined by subject self-report during screening and I/E criteria assessment at study start. (Three events of irregularities in radial pulse with thirty seconds).

结局指标

主要结局

To determine the respiration rate performance in healthy adult volunteers during motion when compared to established technologies for measuring parameters related to respiration.

时间窗: up to 3 months

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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