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• W4246555930 abstract "<sec> <title>BACKGROUND</title> A decrease in the level of pulse oxygen saturation as measured by pulse oximetry (SpO₂) is an indicator of hypoxemia that may occur in various respiratory diseases, such as chronic obstructive pulmonary disease (COPD), sleep apnea syndrome, and COVID-19. Currently, no mass-market wrist-worn SpO₂ monitor meets the medical standards for pulse oximeters. </sec> <sec> <title>OBJECTIVE</title> The main objective of this monocentric and prospective clinical study with single-blind analysis was to test and validate the accuracy of the reflective pulse oximeter function of the Withings ScanWatch to measure SpO₂ levels at different stages of hypoxia. The secondary objective was to confirm the safety of this device when used as intended. </sec> <sec> <title>METHODS</title> To achieve these objectives, we included 14 healthy participants aged 23-39 years in the study, and we induced several stable plateaus of arterial oxygen saturation (SaO₂) ranging from 100%-70% to mimic nonhypoxic conditions and then mild, moderate, and severe hypoxic conditions. We measured the SpO₂ level with a Withings ScanWatch on each participant’s wrist and the SaO₂ from blood samples with a co-oximeter, the ABL90 hemoximeter (Radiometer Medical ApS). </sec> <sec> <title>RESULTS</title> After removal of the inconclusive measurements, we obtained 275 and 244 conclusive measurements with the two ScanWatches on the participants’ right and left wrists, respectively, evenly distributed among the 3 predetermined SpO₂ groups: SpO₂≤80%, 80%&lt;SpO₂≤90%, and 90%&lt;SpO₂. We found a strong association and a high level of agreement between the measurements collected from the devices, with high Pearson correlation coefficients of <i>r</i>=0.944 and <i>r</i>=0.954 on the correlation plots, low Pearson correlation coefficients of <i>r</i>=0.083 (<i>P</i>=.17) and <i>r</i>=0.23 (<i>P</i>=.001) on Bland-Altman plots, biases of 0.98% (95% CI 0.65-1.32) and 1.56% (95% CI 1.24-1.87), and root mean square errors of 2.97% and 3.00% from the participants’ right and left hands, respectively. </sec> <sec> <title>CONCLUSIONS</title> In conclusion, the Withings ScanWatch is able to measure SpO₂ levels with adequate accuracy at a clinical grade. No undesirable effects or adverse events were reported during the study. </sec> <sec> <title>CLINICALTRIAL</title> ClinicalTrials.gov NCT04380389; http://clinicaltrials.gov/ct2/show/NCT04380389 </sec>" @default.
• W4246555930 created "2022-05-12" @default.
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• W4246555930 date "2021-02-01" @default.
• W4246555930 modified "2023-09-25" @default.
• W4246555930 title "Validation of the Withings ScanWatch as a Wrist-Worn Reflective Pulse Oximeter: Prospective Interventional Clinical Study (Preprint)" @default.
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• W4246555930 doi "https://doi.org/10.2196/preprints.27503" @default.
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