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The aim of the study is to compare the measurement of peripheral blood oxygen saturation using a smartwatch with a medical-grade pulse oximeter.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypoxic | Experimental | Participants inhale ambient air, the hypoxic gas mixture, and ambient air. |
|
| Hypercapnic | Experimental | Participants inhale ambient air, the hypercapnic and hypoxic gas mixture, and the ambient air. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoxic gas mixture | Other | Gas mixture of 12% O2 and 88% N2 for five minutes. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Similarity of SpO2 readings | The agreement of SpO2 measurements of both monitoring devices will be evaluated. | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veronika Rafl Huttova | Czech Technical University in Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Biomedical Engineering, Czech Technical University in Prague | Kladno | 27201 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28802098 | Background | 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. | |
| 32633688 | Background | 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. |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D006935 | Hypercapnia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C041364 | nitrox |
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All participants go through all study arms, in random order. Two measuring devices are active simultaneously during measurement on each participant and their functioning is compared.
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| Hypercapnic and hypoxic gas mixture |
| Other |
Gas mixture of 12% O2, 5% CO2, and 88% N2 for five minutes. |
|
| SpO2 measurement | Other | Two SpO2 measuring devices are active simultaneously during measurement. |
|
| 36249475 | Derived | Rafl J, Bachman TE, Rafl-Huttova V, Walzel S, Rozanek M. Commercial smartwatch with pulse oximeter detects short-time hypoxemia as well as standard medical-grade device: Validation study. Digit Health. 2022 Oct 11;8:20552076221132127. doi: 10.1177/20552076221132127. eCollection 2022 Jan-Dec. |