Evaluation of SpO2 Measurement Using a Smartwatch

Hypoxia Clinical Trial

— ESMUS  

Official title:

Evaluation of SpO2 Measurement Using a Smartwatch

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780724
• Other study ID #: smartwatch21
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: March 30, 2021

Study information

• Verified date: January 2022
• Source: Czech Technical University in Prague
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercapnia
• Hypoxia

Intervention

Other:
• Hypoxic gas mixture
Gas mixture of 12% O2 and 88% N2 for five minutes.
• Hypercapnic and hypoxic gas mixture
Gas mixture of 12% O2, 5% CO2, and 88% N2 for five minutes.
• SpO2 measurement
Two SpO2 measuring devices are active simultaneously during measurement.

Locations

Country	Name	City	State
Czechia	Faculty of Biomedical Engineering, Czech Technical University in Prague	Kladno

Sponsors (1)

Lead Sponsor	Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

Lauterbach CJ, Romano PA, Greisler LA, Brindle RA, Ford KR, Kuennen MR. Accuracy and Reliability of Commercial Wrist-Worn Pulse Oximeter During Normobaric Hypoxia Exposure Under Resting Conditions. Res Q Exerc Sport. 2021 Sep;92(3):549-558. doi: 10.1080/02701367.2020.1759768. Epub 2020 Jul 7. — View Citation

Rafl J, Kulhanek F, Kudrna P, Ort V, Roubik K. Response time of indirectly accessed gas exchange depends on measurement method. Biomed Tech (Berl). 2018 Nov 27;63(6):647-655. doi: 10.1515/bmt-2017-0070. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Similarity of SpO2 readings	The agreement of SpO2 measurements of both monitoring devices will be evaluated.	2 hours