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临床试验/NCT02657720
NCT02657720已完成4 期

Comparison Between Different Technologies That Measure Respiratory Rate

Oridion2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2015年7月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
29
试验地点
2
主要终点
The influence of different breathing rates.on the accuracy of respiratory rates in breaths per minute as measured by the tested devices compared to the reference device.

研究概览

简要总结

Respiration rate is a critical vital sign that provides early detection of respiratory compromise and patient distress. Continuous monitoring of respiration rate is performed in patients under different clinical conditions, including post-surgery or different respiratory diseases. Clinician observation, pulse oximetry, and capnography are used individually or in combination to monitor ventilation during sedation and on post-surgical patients. The American Society of Anesthesiologists mandates the monitoring of respiration by measuring end tidal carbon dioxide (RRetco2) during procedural sedation and anesthesia. Other techniques for respiration rate measurement include different technologies such as acoustic respiratory rate (RRa). The aim of this study is to compare the accuracy of RRetco2 and RRa under certain respiratory conditions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Without Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
  • Without Clinical diagnosis of heart disease.

排除标准

  • Want to be excluded
  • Breathing difficulties
  • Unabling or unwilling to follow the protocol.
  • Contact allergy to the adhesive neck sensor.

结局指标

主要结局

The influence of different breathing rates.on the accuracy of respiratory rates in breaths per minute as measured by the tested devices compared to the reference device.

时间窗: six months

Respiratory rate will be measured with the monitors Radical 7 device, Capnostream20p and PTAF2 (flow meter), the latter as a reference device and recorded in the following units: breaths per minute. Differences in accuracy as compared to the reference device and differences in percentage of time in which the device was accurate will be analyzed offline.

次要结局

  • The influence of hearing or performing noises on the accuracy of respiratory rates in breaths per minute as measured by the tested devices compared to the reference device.(six months)

研究者

发起方
Oridion
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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