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临床试验/NCT04780724
NCT04780724已完成不适用

Evaluation of SpO2 Measurement Using a Smartwatch

Czech Technical University in Prague1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Similarity of SpO2 readings

研究概览

简要总结

The aim of the study is to compare the measurement of peripheral blood oxygen saturation using a smartwatch with a medical-grade pulse oximeter.

详细描述

Recently, wearables, like smartwatches, have been gaining new possibilities in monitoring biological signals and they are used for home monitoring of health conditions. The newest models of smartwatches even measure peripheral blood oxygen saturation (SpO2). The study aims to compare the measurement of peripheral blood oxygen saturation using the latest smartwatch with a medical-grade pulse oximeter under the condition of normobaric hypoxia. Healthy participants will breathe oxygen-reduced mixtures (the hypoxic gas mixture of 12% O2 and 88% N2 and the hypercapnic and hypoxic gas mixture of 12% O2, 5% CO2, and 83% N2), which will temporarily reduce their blood oxygen saturation. SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. The agreement of the measurements of both devices will be evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •healthy volunteers from the Czech Technical University

排除标准

  • •pregnancy
  • •severe cardiovascular conditions
  • •severe asthma or other severe respiratory conditions
  • •injury to the upper limbs or hands that could affect the peripheral perfusion
  • •hypotension or hypertension

研究组 & 干预措施

Hypoxic

Experimental

Participants inhale ambient air, the hypoxic gas mixture, and ambient air.

干预措施: SpO2 measurement (Other)

Hypoxic

Experimental

Participants inhale ambient air, the hypoxic gas mixture, and ambient air.

干预措施: Hypoxic gas mixture (Other)

Hypercapnic

Experimental

Participants inhale ambient air, the hypercapnic and hypoxic gas mixture, and the ambient air.

干预措施: Hypercapnic and hypoxic gas mixture (Other)

Hypercapnic

Experimental

Participants inhale ambient air, the hypercapnic and hypoxic gas mixture, and the ambient air.

干预措施: SpO2 measurement (Other)

结局指标

主要结局

Similarity of SpO2 readings

时间窗: 2 hours

The agreement of SpO2 measurements of both monitoring devices will be evaluated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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