Evrard Charles, El Attaoui Amina, Pistea Cristina, Enache Irina, Marriott Mark, Mayaud Louis, Charloux Anne, Geny Bernard
Biomedicine Research Center of Strasbourg (CRBS), UR 3072, "Mitochondria, Oxidative Stress and Muscle Plasticity", Faculty of Medicine, University of Strasbourg, 67000 Strasbourg, France.
Department of Physiology and Functional Explorations, University Hospital of Strasbourg, 67000 Strasbourg, France.
Sensors (Basel). 2024 Dec 28;25(1):127. doi: 10.3390/s25010127.
The continuous monitoring of oxygen saturation (SpO) and respiratory rates (RRs) are major clinical issues in many cardio-respiratory diseases and have been of tremendous importance during the COVID-19 pandemic. The early detection of hypoxemia was crucial since it precedes significant complications, and SpO follow-up allowed early hospital discharge in patients needing oxygen therapy. Nevertheless, fingertip devices showed some practical limitations. In this study, we investigated the reliability of the new Multisense pulse oximetry system compared to a reference pulse oximeter (Vyntus CPX Pulse Oximeter) during hypoxia. In a population of sixteen healthy male subjects (mean age: 31.5 ± 7.0 years, BMI: 24.9 ± 3.6 kg/m², and 35% with darker skin tones), simultaneous SpO and RR measurements were collected over 12.4 h, during which FiO was progressively reduced from 21% to 10.5%. The average root mean square error (ARMS) of SpO for Multisense placed on the back and chest was 2.94% and 2.98%, respectively, with permutation testing confirming a significant ARMS below 3.5% for both positions and no statistically significant difference in the ARMS between patch placements. Positive correlations and acceptable accuracy between devices were observed at both locations (r = 0.92, < 0.001 and r = 0.90, < 0.001 for back and chest placements, respectively). Bland-Altman analysis further indicated limits of agreement that support consistency across placements, with similar agreement levels noted across skin tones. Similar findings were obtained with the RR measurements. In conclusion, Multisense demonstrated robust accuracy in measuring SpO and RRs during hypoxia in humans comparable to standard hospital-grade equipment. The effectiveness of the findings suggests that this wearable device is a valuable tool for the continuous monitoring of SpO and RRs, potentially enhancing patient safety and optimizing hospital resource allocation. Nevertheless, to overcome study limitations and allow generalized use, further work on a larger population sample, including more subjects with a high phototype and desaturation below 80%, would be useful.
持续监测血氧饱和度（SpO）和呼吸频率（RRs）是许多心肺疾病中的主要临床问题，在新冠疫情期间也极为重要。低氧血症的早期检测至关重要，因为它先于严重并发症出现，而对SpO的随访能让需要氧疗的患者提前出院。然而，指尖设备存在一些实际局限性。在本研究中，我们调查了新型多传感脉搏血氧饱和度测定系统与参考脉搏血氧仪（Vyntus CPX脉搏血氧仪）在低氧状态下相比的可靠性。在16名健康男性受试者群体中（平均年龄：31.5±7.0岁，体重指数：24.9±3.6kg/m²，35%为肤色较深者），在12.4小时内同时收集SpO和RR测量值，在此期间，吸入氧分数（FiO）从21%逐渐降至10.5%。置于背部和胸部的多传感设备的SpO平均均方根误差（ARMS）分别为2.94%和2.98%，置换检验证实两个位置的ARMS均显著低于3.5%，且贴片位置之间的ARMS无统计学显著差异。在两个位置均观察到设备之间存在正相关且准确性可接受（背部和胸部贴片位置的相关系数r分别为0.92，P<0.001和0.90，P<0.001）。布兰德-奥特曼分析进一步表明一致性界限支持不同贴片位置之间的一致性，不同肤色的一致性水平相似。RR测量也得到了类似结果。总之，多传感设备在人体低氧状态下测量SpO和RRs时表现出强大的准确性，可与标准医院级设备相媲美。研究结果的有效性表明，这种可穿戴设备是持续监测SpO和RRs的有价值工具，可能会提高患者安全性并优化医院资源分配。然而，为克服研究局限性并实现广泛应用，对更大规模人群样本开展进一步研究将是有益的，包括更多高肤色类型和血氧饱和度低于80%的受试者。
