Accuracy of a New Pulse Oximetry in Detection of Arterial Oxygen Saturation and Heart Rate Measurements: The SOMBRERO Study

Abstract

Early diagnosis and continuous monitoring of respiratory failure (RF) in the course of the most prevalent chronic cardio-vascular (CVD) and respiratory diseases (CRD) are a clinical, unresolved problem because wearable, non-invasive, and user-friendly medical devices, which could grant reliable measures of the oxygen saturation (SpO2) and heart rate (HR) in real-life during daily activities are still lacking. In this study, we investigated the agreement between a new medical wrist-worn device (BrOxy M) and a reference, medical pulseoximeter (Nellcor PM 1000N). Twelve healthy volunteers (aged 20–51 years, 84% males, 33% with black skin, obtaining, during the controlled hypoxia test, the simultaneous registration of 219 data pairs, homogeneously deployed in the levels of Sat.O2 97%, 92%, 87%, 82% [ISO 80601-2-61:2017 standard (paragraph EE.3)]) were included. The paired T test 0 and the Bland-Altman plot were performed to assess bias and accuracy. SpO2 and HR readings by the two devices resulted significantly correlated (r = 0.91 and 0.96, p < 0.001, respectively). Analyses excluded the presence of proportional bias. For SpO2, the mean bias was −0.18% and the accuracy (ARMS) was 2.7%. For HR the mean bias was 0.25 bpm and the ARMS3.7 bpm. The sensitivity to detect SpO2 ≤ 94% was 94.4%. The agreement between BrOxy M and the reference pulse oximeter was “substantial” (for SpO2 cut-off 94% and 90%, k = 0.79 and k = 0.80, respectively). We conclude that BrOxy M demonstrated accuracy, reliability and consistency in measuring SpO2 and HR, being fully comparable with a reference medical pulseoxymeter, with no adverse effects. As a wearable device, Broxy M can measure continually SpO2 and HR in everyday life, helping in detecting and following up CVD and CRD subjects.

A method of determining anaerobic threshold from percutaneous oxygen saturation

“…Therefore, our method to calculate AT automatically from SpO 2 and PR data obtained by pulse oximetry can potentially be a noninvasive and simple alternative method of measuring AT. For SpO 2 and PR measurements, a new medical wrist-worn device has been shown to be sufficiently accurate, reliable, and consistent compared to medical pulse oximeters, with no side effects 38 . In the future, our method could be extended to wearable devices to continuously measure SpO 2 and PR in daily life, which could contribute to not only improving health and performance by providing optimal exercise intensity but also detecting cardiovascular diseases.…”

A scoping review of mHealth technologies for opioid overdose prevention, detection and response

“…Similarly, Chan et al's system that automatically triggers an injection of naloxone after cessation of breathing of over 15 s. In studies of opioid-induced respiratory depression, however, levels below 90% SpO 2 and apnoea above 10-to 15 s were frequently seen without participants requiring any intervention or appearing visibly intoxicated which could mean that these thresholds for action are not sensitive enough [53,54,57]. More broadly, there are also contradicting findings in validation studies for wearable devices compared to medical grade, with some commercially available devices failing to meet pre-defined accuracy guidelines for SpO 2 [32,58,59].…”

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“…with data analysed and interpreted by a specialist, even operating remotely. In the scientific literature this device has been tested with a standard [ 115 ] reference, medical pulse oximeter (Nellcor PM 1000N). SpO 2 and HR readings by the two devices resulted significantly correlated (r=0.91 and 0.96, p<0.001, respectively) and analyses excluded the presence of proportional bias.…”