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

一种新型连续实时无创二氧化碳监测仪，有助于防止服务不足的少数族裔因阿片类药物过量而死亡

• 批准号: 10680718
• 负责人: Xudong Ge
• 金额: $ 51.05万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-06 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10680718
• 关键词: Adult; Affect; Age; Animal Experiments; Animal Model; Animals; Appearance; Area; Arterial Lines; Automation; Black Populations; Blood; Blood Circulation; Blood Gas Analysis; Blood gas; Blood specimen; Body Temperature; Calibration; Carbon Dioxide; Centers for Disease Control and Prevention (U.S.); Cessation of life; Communities; Computer software; Contusions; Data; Depressed mood; Detection; Devices; Diffusion; Disadvantaged; Early Diagnosis; Elements; Evaluation; FDA approved; Family suidae; Focal Infection; Frequencies; Future; Gases; General Anesthesia; Goals; Gold; Heating; Heel; Height; Home; Hour; Human; Hydrophobicity; Individual; Inequality; Injections; Magnetism; Measurement; Measures; Mechanical ventilation; Membrane; Miniaturization; Minority Groups; Monitor; Morphine; Naloxone; Opioid; Output; Overdose; Partial Pressure; Patients; Performance; Perfusion; Persons; Pharmaceutical Preparations; Prevention; Procedures; Pump; Rest; Safety; Sampling; Savings; Shapes; Shunt Device; Signal Transduction; Site; Skin; Skin Temperature; Structure; System; Tennis; Testing; Thick; Time; Transcutaneous partial pressure of carbon dioxide result; Ventilatory Depression; Visualization; Weight; Work; arm; base; biomaterial compatibility; black men; blood gas analyzer; design; digital; experimental study; home test; improved; instrument; miniaturize; minority communities; monitoring device; neonate; novel; operation; opioid epidemic; opioid mortality; opioid overdose; prevent; prototype; rapid detection; recruit; respiratory; response; safety assessment; sensor; sex; side effect; skin burn; stem; trend; underserved minority; ventilation; wearable device

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.

项目摘要 根据疾病控制中心（CDC）的数据，阿片类药物的数量呈上升趋势， 相关死亡，1999年至2019年期间共有近60万人死亡。2021年，CDC 确定阿片类药物过量死亡在黑人中显着上升，特别是黑人男性。 尽管向阿片类药物过量的个体施用纳洛酮以逆转 呼吸抑制，还是有很多人因为没有及时使用纳洛酮而死亡。 因此，及时发现呼吸抑制并自动给予药物纳洛酮， 过量服用阿片类药物的人是挽救他们生命的关键。虽然动脉血气 测量仍然是指导呼吸管理的金标准， 留置动脉管线或间歇性动脉或足跟血液取样使得其不适用于家庭测试。 在20世纪70年代引入经皮监测器以测量经皮CO2分压 当传感器下方的皮肤加热至42-44°C时，其接近动脉值。 缺点包括皮肤灼伤的可能性，频繁的传感器位置变化和重新校准。TcpCO2 在分流或通气-灌注患者中，监测比呼气末CO2监测更准确 并且可以用于诸如高频或无创通气的情况，其中潮气末 二氧化碳监测不能。虽然传统的经皮监测仪具有非侵入性的优点， 测量时，测量需要15-20分钟的加热时间才能达到稳定值， 皮肤温度达到42摄氏度或更高。此外，这些设备体积大，价格昂贵（约25，000美元）， 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CO2的呼吸抑制。这将有助于 预防和治疗受阿片类药物过度影响的社区 过量死亡该监测器基于CO2经皮扩散速率，将在非 它可以快速检测阿片类药物过量引起的呼吸抑制， 然后能够及时地自动给予药物纳洛酮，从而优化患者的 生存原型将在20~50名受试者中进行测试，以确定安全性、准确性和副作用， 如果有话，在长期连续使用后。将进行动物研究，以观察该装置是否可以拾取 吗啡注射引起的血CO2变化。