The Use of Wearable Pulse Oximeters in the Prompt Detection of Hypoxemia and During Movement: Diagnostic Accuracy Study (Preprint)
Santos M., Vollam S., Pimentel MAF., Areia C., Young L., Roman C., Ede J., Piper P., King E., Harford M., Shah A., Gustafson O., Tarassenko L., Watkinson P.
BACKGROUND Commercially available wearable (ambulatory) pulse oximeters have been recommended as a method for managing patients at risk of physiological deterioration, such as active patients with COVID-19 disease receiving care in hospital isolation rooms; however, their reliability in usual hospital settings is not known. OBJECTIVE We report the performance of wearable pulse oximeters in a simulated clinical setting when challenged by motion and low levels of arterial blood oxygen saturation (SaO<sub>2</sub>). METHODS The performance of 1 wrist-worn (Wavelet) and 3 finger-worn (CheckMe O2+, AP-20, and WristOx2 3150) wearable, wireless transmission–mode pulse oximeters was evaluated. For this, 7 motion tasks were performed: at rest, sit-to-stand, tapping, rubbing, drinking, turning pages, and using a tablet. Hypoxia exposure followed, in which inspired gases were adjusted to achieve decreasing SaO<sub>2</sub> levels at 100%, 95%, 90%, 87%, 85%, 83%, and 80%. Peripheral oxygen saturation (SpO<sub>2</sub>) estimates were compared with simultaneous SaO<sub>2</sub> samples to calculate the root-mean-square error (RMSE). The area under the receiver operating characteristic curve was used to analyze the detection of hypoxemia (ie, SaO<sub>2</sub><90%). RESULTS SpO<sub>2</sub> estimates matching 215 SaO<sub>2</sub> samples in both study phases, from 33 participants, were analyzed. Tapping, rubbing, turning pages, and using a tablet degraded SpO<sub>2</sub> estimation (RMSE>4% for at least 1 device). All finger-worn pulse oximeters detected hypoxemia, with an overall sensitivity of ≥0.87 and specificity of ≥0.80, comparable to that of the Philips MX450 pulse oximeter. CONCLUSIONS The SpO<sub>2</sub> accuracy of wearable finger-worn pulse oximeters was within that required by the International Organization for Standardization guidelines. Performance was degraded by motion, but all pulse oximeters could detect hypoxemia. Our findings support the use of wearable, wireless transmission–mode pulse oximeters to detect the onset of clinical deterioration in hospital settings. CLINICALTRIAL ISRCTN Registry 61535692; http://www.isrctn.com/ISRCTN61535692 INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2019-034404