Respiratory Disease Unit, G. Mazzini Hospital, 64100 Teramo, Italy.
Presidio PneumoTisiologico Territoriale ASL 02, 66100 Chieti, Italy.
Sensors (Basel). 2022 Jul 3;22(13):5031. doi: 10.3390/s22135031.
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.
早期诊断和持续监测最常见的慢性心血管（CVD）和呼吸系统疾病（CRD）过程中的呼吸衰竭（RF）是一个临床未解决的问题，因为目前还缺乏可穿戴、非侵入性和用户友好的医疗设备，这些设备可以在日常生活活动中提供可靠的血氧饱和度（SpO2）和心率（HR）测量。在这项研究中，我们研究了一种新型腕戴式医疗设备（BrOxy M）与参考医疗脉搏血氧仪（Nellcor PM 1000N）之间的一致性。12 名健康志愿者（年龄 20-51 岁，84%为男性，33%为黑人皮肤，在受控低氧测试中同时记录 219 对数据，均匀分布在 Sat.O2 97%、92%、87%、82%[ISO 80601-2-61：2017 标准（段落 EE.3）]水平）被纳入研究。使用配对 T 检验和 Bland-Altman 图评估偏差和准确性。两种设备的 SpO2 和 HR 读数呈显著相关（r = 0.91 和 0.96，p < 0.001）。分析排除了存在比例偏差的可能性。对于 SpO2，平均偏差为-0.18%，准确性（ARMS）为 2.7%。对于 HR，平均偏差为 0.25 bpm，ARMS 为 3.7 bpm。检测 SpO2 ≤ 94%的灵敏度为 94.4%。BrOxy M 与参考脉搏血氧仪之间的一致性为“高度一致”（SpO2 截止值为 94%和 90%时，k 值分别为 0.79 和 0.80）。我们得出结论，BrOxy M 在测量 SpO2 和 HR 方面表现出准确性、可靠性和一致性，与参考医疗脉搏血氧仪完全可比，没有不良影响。作为一种可穿戴设备，BrOxy M 可以在日常生活中持续测量 SpO2 和 HR，有助于发现和监测 CVD 和 CRD 患者。
