Kramer Marcus, Lobbestael Aaron, Barten Emily, Eian John, Rausch Gregory
Nonin Medical, Inc., 13700 1st Avenue North, Plymouth MN 55441-5443.
Mil Med. 2017 Mar;182(S1):92-98. doi: 10.7205/MILMED-D-16-00129.
For decades pulse oximeters designed for use on the head, hands, or feet have provided invaluable estimates of oxygen saturation to medical personal attending to combat casualties. However, traditional placement sites are not ideal for the relatively new paradigm of continuous battlefield telemonitoring. To assess the feasibility of oximetry on nontraditional body sites, 42 healthy volunteers were enrolled, consented, and underwent an industry standard induced-hypoxia study. During the study volunteers used prototype wearable oximeters, designed for the torso, arms, and legs. Subsets (size n) of the volunteers had the wearables placed at the following body sites, and achieved accuracies (A, root-mean-square difference) of the following: calf 1.7% (n = 26); bicep 3.1% (n = 12); forearm 3.4% (n = 11); pectoral 2.9% (n = 42); sternum 2.9% (n = 13). In keeping with regulatory guidance calibrations with an A of less than 3.5% are acceptable for potential future development. Additionally, a new method was developed to enable accurate reporting of respiration rate from the pectoral oximeter, A of 1.1 breaths per minute (n = 10). This study demonstrates the feasibility of monitoring oxygen saturation and respiration rate from nontraditional sites via a wearable pulse oximeter.
几十年来,为头部、手部或足部设计的脉搏血氧仪为救治战斗伤员的医护人员提供了极为重要的血氧饱和度估计值。然而,传统的放置部位对于相对较新的持续战场远程监测模式并不理想。为了评估在非传统身体部位进行血氧测定的可行性,招募了42名健康志愿者,他们签署了知情同意书,并接受了一项行业标准的诱导性低氧研究。在研究过程中,志愿者使用了为躯干、手臂和腿部设计的原型可穿戴式血氧仪。部分志愿者(每组人数为n)将可穿戴设备放置在以下身体部位,并获得了以下准确率(A,均方根差):小腿1.7%(n = 26);二头肌3.1%(n = 12);前臂3.4%(n = 11);胸部2.9%(n = 42);胸骨2.9%(n = 13)。根据监管指南,对于未来潜在的发展而言,A值小于3.5%的校准是可以接受的。此外,还开发了一种新方法,能够准确报告来自胸部血氧仪的呼吸频率,A值为每分钟1.1次呼吸(n = 10)。这项研究证明了通过可穿戴脉搏血氧仪在非传统部位监测血氧饱和度和呼吸频率的可行性。