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Comparison of SpO2 Measurement Accuracy of Different Types of Smartwatches — CSMADTS  

Hypoxia Clinical Trial

Official title:
Comparison of SpO2 Measurement Accuracy of Different Types of Smartwatches

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05789563
Study type Interventional
Source Czech Technical University in Prague
Contact
Status Enrolling by invitation
Phase N/A
Start date March 17, 2023
Completion date June 28, 2023
View Details
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