NCT05657288

SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter During Hypoxia

SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Czech Technical University in Prague · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The aim of the project is to experimentally compare SpO2 measured on a wrist by commercial Smartwach and on a finger measured by a medical-grade pulse oximeter in healthy humans during gradual desaturation in the range of 60-100% SpO2 and simultaneously during a step change from the hypoxic phase to the recovery phase (return to physiological values).

Detailed description

The newest models of smartwatches measure peripheral blood oxygen saturation (SpO2) and the technology is rapidly improving. The results of individual studies on the accuracy of SpO2 measurement using smartwatches from different brands are still inconclusive. 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. 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.

Conditions

• Hypoxia
• Pulse Oximetry

Interventions

Type	Name	Description
OTHER	Breathing mixtures of O2 and N2 and monitoring SpO2 on finger and left wrist	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 whole experiment, non-invasive SpO2 measurements will be performed on the middle finger and on the wrist of left hand.

Timeline

• Start date: 2022-12-28
• Primary completion: 2023-05-20
• Completion: 2023-12-20
• First posted: 2022-12-20
• Last updated: 2023-03-17

Locations

1 site across 1 country: Czechia