Evaluation of SpO2 Measurement Using a Smartwatch

Not Applicable

Completed

• Conditions: Hypoxia; Hypercapnia
• Interventions: Other: Hypercapnic and hypoxic gas mixture; Other: Hypoxic gas mixture; Other: SpO2 measurement

• Registration Number: NCT04780724
• Lead Sponsor: Czech Technical University in Prague

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2021-02-15
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-03
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• healthy volunteers from the Czech Technical University

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hypercapnic	Hypercapnic and hypoxic gas mixture	Participants inhale ambient air, the hypercapnic and hypoxic gas mixture, and the ambient air.
Hypercapnic	SpO2 measurement	Participants inhale ambient air, the hypercapnic and hypoxic gas mixture, and the ambient air.
Hypoxic	SpO2 measurement	Participants inhale ambient air, the hypoxic gas mixture, and ambient air.
Hypoxic	Hypoxic gas mixture	Participants inhale ambient air, the hypoxic gas mixture, and ambient air.

Primary Outcome Measures

Name	Time	Method
Similarity of SpO2 readings	2 hours	The agreement of SpO2 measurements of both monitoring devices will be evaluated.

Trial Locations

Locations (1)

Faculty of Biomedical Engineering, Czech Technical University in Prague; 🇨🇿 Kladno, Czechia