Comparison of SpO2 Measurement Accuracy of Different Types of Smartwatches

Czech Technical University in Prague1 个研究点分布在 1 个国家目标入组 18 人2023年3月17日

概览

简要总结

The aim of the study is to compare the accuracy of peripheral blood oxygen saturation measurements using smartwatches from three manufacturers compared to a standard medical pulse oximeter.

详细描述

The aim is to create a study that compares multiple smartwatch models simultaneously with a standard medical pulse oximeter using a single measurement methodology. According to the available literature, no such study exists. The methodology of the study and the subsequent statistical evaluation are based on the guidelines of the standard ČSN EN ISO 80601-2-61, which specifies requirements for the basic safety and necessary functionality of pulse oximetry devices. The comparison will be performed non-invasively in healthy volunteers during gradual desaturation in the range of 70-100 % SpO2 (normobaric hypoxia). The data obtained could help to increase the awareness of the possibilities of SpO2 monitoring using smartwatches in medical conditions that are manifested by a decrease in SpO2 level over a longer time period, where measurement with a conventional oximeter is impractical.

注册库

clinicaltrials.gov

开始日期

2023年3月17日

结束日期

2023年6月28日

最后更新

上个月

研究类型

Interventional

研究设计

Crossover

性别

All

研究者

发起方

Czech Technical University in Prague

责任方

Sponsor

入排标准

入选标准

•Passing the initial examination, which will determine the following data: wrist circumference, heart rate, blood pressure and blood oxygen saturation

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

First smartwatch model

Volunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously.

干预措施: Hypoxia and Smartwatch model

Second smartwatch model

Volunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously.

干预措施: Hypoxia and Smartwatch model

Third smartwatch model

Volunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously.

干预措施: Hypoxia and Smartwatch model