Autor: |
Giulia Gerboni, Giulia Comunale, Weixuan Chen, Jessie Lever Taylor, Matteo Migliorini, Rosalind Picard, Marisa Cruz, Giulia Regalia |
Jazyk: |
angličtina |
Rok vydání: |
2023 |
Předmět: |
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Zdroj: |
Frontiers in Digital Health, Vol 5 (2023) |
Druh dokumentu: |
article |
ISSN: |
2673-253X |
DOI: |
10.3389/fdgth.2023.1258915 |
Popis: |
IntroductionRespiratory diseases such as chronic obstructive pulmonary disease, obstructive sleep apnea syndrome, and COVID-19 may cause a decrease in arterial oxygen saturation (SaO2). The continuous monitoring of oxygen levels may be beneficial for the early detection of hypoxemia and timely intervention. Wearable non-invasive pulse oximetry devices measuring peripheral oxygen saturation (SpO2) have been garnering increasing popularity. However, there is still a strong need for extended and robust clinical validation of such devices, especially to address topical concerns about disparities in performances across racial groups. This prospective clinical validation aimed to assess the accuracy of the reflective pulse oximeter function of the EmbracePlus wristband during a controlled hypoxia study in accordance with the ISO 80601-2-61:2017 standard and the Food & Drug Administration (FDA) guidance.MethodsHealthy adult participants were recruited in a controlled desaturation protocol to reproduce mild, moderate, and severe hypoxic conditions with SaO2 ranging from 100% to 70% (ClinicalTrials.gov registration #NCT04964609). The SpO2 level was estimated with an EmbracePlus device placed on the participant's wrist and the reference SaO2 was obtained from blood samples analyzed with a multiwavelength co-oximeter.ResultsThe controlled hypoxia study yielded 373 conclusive measurements on 15 subjects, including 30% of participants with dark skin pigmentation (V–VI on the Fitzpatrick scale). The accuracy root mean square (Arms) error was found to be 2.4%, within the 3.5% limit recommended by the FDA. A strong positive correlation between the wristband SpO2 and the reference SaO2 was observed (r = 0.96, P |
Databáze: |
Directory of Open Access Journals |
Externí odkaz: |
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