Evaluation of SpO2 Measurement Using a Smartwatch (ESMUS)

Czech Technical University in Prague

Status: Completed

Conditions: Hypercapnia; Hypoxia

Treatments: Other: Hypercapnic and hypoxic gas mixture; Other: Hypoxic gas mixture; Other: SpO2 measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT04780724

smartwatch21

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Hypoxic

Experimental group

Description:

Participants inhale ambient air, the hypoxic gas mixture, and ambient air.

Treatment:

Other: SpO2 measurement

Other: Hypoxic gas mixture

Hypercapnic

Experimental group

Description:

Participants inhale ambient air, the hypercapnic and hypoxic gas mixture, and the ambient air.

Treatment:

Other: Hypercapnic and hypoxic gas mixture

Other: SpO2 measurement