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临床试验/NCT04580615
NCT04580615Unknown不适用

Anonymized Data Collection From the CardiacSense1 and Other Modalities for the Purpose of Developing a System for Monitoring of Respiratory Rate

CardiacSense Ltd.2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年6月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Respiratory rate

研究概览

简要总结

Collect data from the CardiacSense1's sensors and Capnograph, for the purpose of developing a wearable system for monitoring of Respiratory Rate (RR) in patients while at hospital

详细描述

Hospitalized subjects, diagnosed with a Respiratory disease or subjects with no known Respiratory disease will be will be connected simultaneously to CardiacSense watch and Capnograph for a duration of at least 30 minutes and up to 24 hours in order to collect data for the purpose of developing a wearable system for monitoring of Respiratory Rate (RR) by the CardiacSense watch.

The CardiacSense1 is a wrist worn device designed to detect atrial fibrillation. CardiacSense1 senses the radial artery inflation and deflation and together with a PPG sensors give an ultimate performance that is superior to PPG only.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

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

  • Age of eighteen (18) year and above
  • Diagnosed with Respiratory disease/impairment or without any known Respiratory disease/impairment
  • Ability and willingness to sign an informed consent form

排除标准

  • Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study
  • Patients with significant co morbidities (assessed by the clinician at screening only
  • Presence of an acute disease process that might interfere with test performance
  • Subjects with PPG SNR <100 indicated by the CardiacSense1 device
  • Women who are pregnant or breastfeeding

结局指标

主要结局

Respiratory rate

时间窗: 24 hours

Capnograph and Cardiacsense1 sensor Respiratory rate

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 (2)

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