Abstract
Pulse oximetry is an important diagnostic tool in monitoring and treating both in-patients and ambulatory patients. Modern pulse oximeters exploit different body sites (eg fingertip, forehead or earlobe). All those are bulky and uncomfortable, resulting in low patient compliance. Therefore, we evaluated the accuracy and precision of a wrist-sensor pulse oximeter (Oxitone-1000, Oxitone Medical) vs. the traditional fingertip device. Fifteen healthy volunteers and 23 patients were recruited. The patient group included chronic obstructive pulmonary disease (COPD) (N = 8), asthma (N = 6), sarcoidosis (N = 5) and others. Basic demographic data, skin tone type, smoking status and medical history were recorded. Blood oxygen level (SpO2) and pulse-rate values were determined by a non-invasive pulse oximeter (Reference, a conventional FDA-cleared fingertip pulse oximeter) and by Oxitone-1000. All tests were performed in singleton and in a blinded fashion. The measurements were done in sitting and standing positions, as well as after a 6-min walk test. The mean age was 60.4 ± 9.83 years, 55% were male. No significant differences were observed between the wrist-sensor and the traditional fingertip pulse oximeters in all tested parameters. Mean SpO2 was 96.45% vs. 97.18% and the mean pulse was 74.64 vs. 74.6 bpm (Oxitone-1000 vs. Reference, respectively, p < 0.0001). Precision rate was 2.28472% and the accuracy was met (Arms -Root mean-square-error < 3%). The Oxitone-1000 is both accurate and precise for SpO2 and pulse measurements during daily activities of pulmonary patients, and is not inferior to standard devices for spot checking or short period examinations. Its wrist-sensor design is comfortable and provides the advantage of extended use.
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Acknowledgements
The statistical analyses was performed by BioStat statistical consulting company, using SAS® v9.4 (SAS®, SAS Institute Cary, NC USA) software.
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Partial funding was received for this research from Oxitone Medical.
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Sarah Kohn is an employee at Oxitone Medical. All other authors have nothing to disclose.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee at MMC and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Guber, A., Epstein Shochet, G., Kohn, S. et al. Wrist-Sensor Pulse Oximeter Enables Prolonged Patient Monitoring in Chronic Lung Diseases. J Med Syst 43, 230 (2019). https://doi.org/10.1007/s10916-019-1317-2
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DOI: https://doi.org/10.1007/s10916-019-1317-2