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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
18
Breathing mixtures of O2 (14 %, 12 %, 10 %) balanced with N2 and monitoring SpO2 by one of the smartwatch models on left wrist and by pulse oximeter on left index finger.
Czech Technical University in Prague
Kladno, Czechia
Similarity of SpO2 readings
The agreement of SpO2 measurements of every model of smartwatches and reference pulse oximeter will be evaluated
Time frame: Under 1 hour
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.