PDF(Pubmed)
Abstract：
BACKGROUND: Pulse oximeters work within the red-infrared wavelengths. Therefore, these oximeters produce erratic results in dark-skinned subjects and in subjects with cold extremities. Pulse oximetry is routinely performed in patients with fever; however, an elevation in body temperature decreases the affinity of hemoglobin for oxygen, causing a drop in oxygen saturation or oxyhemoglobin concentrations.
OBJECTIVE: We aimed to determine whether our new investigational device, the Shani device or SH1 (US Patent 11191460), detects a drop in oxygen saturation or a decrease in oxyhemoglobin concentrations.
METHODS: An observational study (phase 1) was performed in two separate groups to validate measurements of hemoglobin and oxygen concentrations, including 39 participants recruited among current university students and staff aged 20-40 years. All volunteers completed baseline readings using the SH1 device and the commercially available Food and Drug Administration-approved pulse oximeter Masimo. SH1 uses two light-emitting diodes in which the emitted wavelengths match with absorption peaks of oxyhemoglobin (hemoglobin combined with oxygen) and deoxyhemoglobin (hemoglobin without oxygen or reduced hemoglobin). Total hemoglobin was calculated as the sum of oxyhemoglobin and deoxyhemoglobin. Subsequently, 16 subjects completed the \"heat jacket study\" and the others completed the \"blood donation study.\" Masimo was consistently used on the finger for comparison. The melanin level was accounted for using the von Luschan skin color scale (VLS) and a specifically designed algorithm. We here focus on the results of the heat jacket study, in which the subject wore a double-layered heated jacket and pair of trousers including a network of polythene tubules along with an inlet and outlet. Warm water was circulated to increase the body temperature by 0.5-0.8 °C above the baseline body temperature. We expected a slight drop in oxyhemoglobin concentrations in the heating phase at the tissue level.
RESULTS: The mean age of the participants was 24.1 (SD 0.8) years. The skin tone varied from 12 to 36 on the VLS, representing a uniform distribution with one-third of the participants having fair skin, brown skin, and dark skin, respectively. Using a specific algorithm and software, the reflection ratio for oxyhemoglobin was displayed on the screen of the device along with direct hemoglobin values. The SH1 device picked up more minor changes in oxyhemoglobin levels after a change in body temperature compared to the pulse oximeter, with a maximum drop in oxyhemoglobin concentration detected of 6.5% and 2.54%, respectively.
CONCLUSIONS: Our new investigational device SH1 measures oxygen saturation at the tissue level by reflectance spectroscopy using green wavelengths. This device fared well regardless of skin color. This device can thus eliminate racial disparity in these key biomarker assessments. Moreover, since the light is shone on the wrist, SH1 can be readily miniaturized into a wearable device.
OBJECTIVE: We aimed to determine whether our new investigational device, the Shani device or SH1 (US Patent 11191460), detects a drop in oxygen saturation or a decrease in oxyhemoglobin concentrations.
METHODS: An observational study (phase 1) was performed in two separate groups to validate measurements of hemoglobin and oxygen concentrations, including 39 participants recruited among current university students and staff aged 20-40 years. All volunteers completed baseline readings using the SH1 device and the commercially available Food and Drug Administration-approved pulse oximeter Masimo. SH1 uses two light-emitting diodes in which the emitted wavelengths match with absorption peaks of oxyhemoglobin (hemoglobin combined with oxygen) and deoxyhemoglobin (hemoglobin without oxygen or reduced hemoglobin). Total hemoglobin was calculated as the sum of oxyhemoglobin and deoxyhemoglobin. Subsequently, 16 subjects completed the \"heat jacket study\" and the others completed the \"blood donation study.\" Masimo was consistently used on the finger for comparison. The melanin level was accounted for using the von Luschan skin color scale (VLS) and a specifically designed algorithm. We here focus on the results of the heat jacket study, in which the subject wore a double-layered heated jacket and pair of trousers including a network of polythene tubules along with an inlet and outlet. Warm water was circulated to increase the body temperature by 0.5-0.8 °C above the baseline body temperature. We expected a slight drop in oxyhemoglobin concentrations in the heating phase at the tissue level.
RESULTS: The mean age of the participants was 24.1 (SD 0.8) years. The skin tone varied from 12 to 36 on the VLS, representing a uniform distribution with one-third of the participants having fair skin, brown skin, and dark skin, respectively. Using a specific algorithm and software, the reflection ratio for oxyhemoglobin was displayed on the screen of the device along with direct hemoglobin values. The SH1 device picked up more minor changes in oxyhemoglobin levels after a change in body temperature compared to the pulse oximeter, with a maximum drop in oxyhemoglobin concentration detected of 6.5% and 2.54%, respectively.
CONCLUSIONS: Our new investigational device SH1 measures oxygen saturation at the tissue level by reflectance spectroscopy using green wavelengths. This device fared well regardless of skin color. This device can thus eliminate racial disparity in these key biomarker assessments. Moreover, since the light is shone on the wrist, SH1 can be readily miniaturized into a wearable device.
摘要：
背景：脉冲血氧计在红红外波长范围内工作。因此,这些血氧计在深色皮肤受试者和四肢寒冷受试者中产生不稳定的结果。脉搏血氧饱和度通常在发热患者中进行；然而，体温升高会降低血红蛋白对氧的亲和力，导致氧饱和度或氧合血红蛋白浓度下降。
目的：我们的目的是确定我们的新研究设备，Shani装置或SH1（美国专利11191460），检测到氧饱和度下降或氧合血红蛋白浓度下降。
方法：在两组中进行了一项观察性研究（第一阶段），以验证血红蛋白和氧浓度的测量值，包括在当前20-40岁的大学生和教职员工中招募的39名参与者。所有志愿者都使用SH1设备和市售食品药品监督管理局批准的脉搏血氧计Masimo完成基线读数。SH1使用两个发光二极管，其中发射波长与氧合血红蛋白（与氧结合的血红蛋白）和脱氧血红蛋白（不含氧的血红蛋白或还原血红蛋白）的吸收峰相匹配。总血红蛋白计算为氧合血红蛋白和脱氧血红蛋白的总和。随后，16名受试者完成了“热套研究”，其他人完成了“献血研究”。“Masimo一直用在手指上进行比较。使用vonLuschan皮肤色标（VLS）和专门设计的算法来计算黑色素水平。我们在这里关注热套研究的结果，受试者穿着双层加热夹克和裤子，包括聚乙烯小管网络以及入口和出口。循环温水以使体温比基线体温高0.5-0.8°C。我们预计在组织水平的加热阶段氧合血红蛋白浓度会略有下降。
结果：参与者的平均年龄为24.1（SD0.8）岁。VLS上的肤色从12到36不等，代表着均匀分布，三分之一的参与者皮肤白皙，棕色皮肤,和深色皮肤,分别。使用特定的算法和软件，氧合血红蛋白的反射比与直接血红蛋白值一起显示在设备的屏幕上.与脉搏血氧计相比，SH1装置在体温变化后发现氧合血红蛋白水平有更小的变化，检测到的氧合血红蛋白浓度最大下降为6.5%和2.54%，分别。
结论：我们的新研究设备SH1通过使用绿色波长的反射光谱法测量组织水平的氧饱和度。无论肤色如何，该设备都表现良好。因此，该设备可以消除这些关键生物标志物评估中的种族差异。此外，因为光线照在手腕上，SH1可以容易地小型化为可穿戴设备。
目的：我们的目的是确定我们的新研究设备，Shani装置或SH1（美国专利11191460），检测到氧饱和度下降或氧合血红蛋白浓度下降。
方法：在两组中进行了一项观察性研究（第一阶段），以验证血红蛋白和氧浓度的测量值，包括在当前20-40岁的大学生和教职员工中招募的39名参与者。所有志愿者都使用SH1设备和市售食品药品监督管理局批准的脉搏血氧计Masimo完成基线读数。SH1使用两个发光二极管，其中发射波长与氧合血红蛋白（与氧结合的血红蛋白）和脱氧血红蛋白（不含氧的血红蛋白或还原血红蛋白）的吸收峰相匹配。总血红蛋白计算为氧合血红蛋白和脱氧血红蛋白的总和。随后，16名受试者完成了“热套研究”，其他人完成了“献血研究”。“Masimo一直用在手指上进行比较。使用vonLuschan皮肤色标（VLS）和专门设计的算法来计算黑色素水平。我们在这里关注热套研究的结果，受试者穿着双层加热夹克和裤子，包括聚乙烯小管网络以及入口和出口。循环温水以使体温比基线体温高0.5-0.8°C。我们预计在组织水平的加热阶段氧合血红蛋白浓度会略有下降。
结果：参与者的平均年龄为24.1（SD0.8）岁。VLS上的肤色从12到36不等，代表着均匀分布，三分之一的参与者皮肤白皙，棕色皮肤,和深色皮肤,分别。使用特定的算法和软件，氧合血红蛋白的反射比与直接血红蛋白值一起显示在设备的屏幕上.与脉搏血氧计相比，SH1装置在体温变化后发现氧合血红蛋白水平有更小的变化，检测到的氧合血红蛋白浓度最大下降为6.5%和2.54%，分别。
结论：我们的新研究设备SH1通过使用绿色波长的反射光谱法测量组织水平的氧饱和度。无论肤色如何，该设备都表现良好。因此，该设备可以消除这些关键生物标志物评估中的种族差异。此外，因为光线照在手腕上，SH1可以容易地小型化为可穿戴设备。
