A novel continuous real-time non-invasive CO2 monitor to help prevent death in the underserved minority population from opioid overdose

项目摘要 根据疾病控制中心(CDC)的数据，阿片类药物的数量一直呈上升趋势。 相关死亡，1999年至2019年期间总共有近60万人死亡。2021年，疾控中心 确定阿片类药物过量死亡在黑人中显著上升，特别是黑人男性。 尽管明显的解决方案是向阿片类药物过量的个人服用纳洛酮以逆转 在呼吸抑制的情况下，仍有许多人因纳洛酮未及时使用而死亡。 因此，及时检测呼吸抑制并自动给药纳洛酮来 过量服用阿片类药物的人是拯救他们生命的关键。虽然动脉血气 测量仍然是指导呼吸管理的金标准，放置 留置动脉管道或间歇性的动脉或脚后跟血液样本使其不适用于家庭测试。 20世纪70年代引入经皮监测仪来测量经皮二氧化碳分压。 (TcpCO2)，接近传感器下面的皮肤加热到42-44°C时的动脉值。 缺点包括潜在的皮肤灼伤、频繁的传感器位置更改和重新校准。三氯甲烷二氧化碳 在分流或机械通气-灌流的患者中，监测比呼气末二氧化碳监测更准确 不平等，可用于高频或非侵入性通气等呼气末 二氧化碳监测不能。尽管传统的经皮监护仪具有无创的优点 测量，测量需要15-20分钟的加热期才能达到稳定值，尽管 皮肤温度达到42C或更高。此外，这些设备体积大，价格昂贵(约2.5万美元)，使 它们也不适用于个人使用。为了遏制阿片类药物危机，我们建议及早发现 通过持续监测经皮二氧化碳呼吸抑制。这将有助于 预防和治疗受阿片类药物影响不成比例的社区 服药过量死亡。该监测仪基于二氧化碳经皮扩散速率，将在非 侵袭性地压在病人的胳膊上。它可以快速检测到阿片类药物过量引起的呼吸抑制，这可以 然后使自动给药及时纳洛酮，从而优化患者的 生死存亡。样机将在20~50名受试者中进行测试，以确定安全性、准确性和副作用， 如有，应在长期连续使用后使用。将进行动物实验，以确定该装置是否能拾取 吗啡注射引起的血二氧化碳含量变化。

Project Summary According to the Center for Disease Control (CDC), there has been an upward trend in the number of opioid- related deaths, with a total of nearly 600,000 deaths during the period 1999 to 2019. In 2021, the CDC determined that opioid overdose deaths rose significantly amongst blacks, especially black males. Despite the apparent solution of administering naloxone to opioid-overdosed individuals to reverse the respiratory depression, many people still died because naloxone was not administered in a timely manner. Therefore, timely detection of respiratory depression and automatic administration of the drug naloxone to individuals who have overdosed on opioids is the key to saving their lives. Although arterial blood gas measurement remains the gold standard for guiding respiratory management, the necessity for placement of indwelling arterial lines or intermittent arterial or heel blood sampling makes it inapplicable for home testing. Transcutaneous monitors were introduced in the 1970s to measure the transcutaneous CO2 partial pressure (tcpCO2) that approximated the arterial value when the skin underneath the sensor was heated to 42-44°C. Disadvantages include potential for skin burns, frequent sensor site changes and re-calibrations. TcpCO2 monitoring is more accurate than end-tidal CO2 monitoring in patients with shunt or ventilation-perfusion inequalities and can be used in situations such as high frequency or non-invasive ventilation where end-tidal CO2 monitoring cannot. Although traditional transcutaneous monitors have the advantage of non-invasive measurement, the measurement needs a 15-20-minute heating period to reach stable values despite raising the skin temperature to 42C or higher. In addition, these devices are large and expensive (~$25,000), making them also inapplicable for personal use. In order to stem the opioid crisis, we propose early detection of respiratory depression by continuous monitoring of transcutaneous CO2. This will help with the prevention and treatment of communities that have been disproportionately affected by opioid overdose deaths. The monitor is based on the CO2 transdermal diffusion rate and will be applied non- invasively on the patient's arm. It can quickly detect opioid overdose-induced respiratory depression, which can then enable an automatic administration of the drug naloxone in a timely manner, thus optimizing the patient's survival. The prototypes will be tested with 20~50 subjects to determine the safety, accuracy, and side effects, if any, after long-term of continuous use. Animal studies will be conducted to see if the device can pick up the blood CO2 changes induced by morphine injection.