Rapid Induction of Therapeutic Hypothermia

快速诱导治疗性低温

• 批准号: 8533550
• 负责人: BENJAMIN R LANE
• 金额: $ 67.67万
• 依托单位: KEY TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-05 至 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8533550
• 关键词: Acute; Adopted; Adoption; Air; Animals; Arrhythmia; Basic Science; Blood Circulation; Blood Vessels; Blood flow; Body Temperature; Brain; Brain Injuries; Cardiac; Cause of Death; Cerebrum; Characteristics; Chemicals; Chills; Clinical; Clinical Trials; Complex; Devices; Drops; Early treatment; Electric Countershock; Emergency medical service; Exhibits; Family suidae; Feedback; Grant; Healthcare Systems; Heart; Heart Arrest; Heat Losses; Heating; Hemorrhage; Hospitals; Human; Human Resources; Human Volunteers; Humidity; Hypotension; Ice; Incentives; Infusion procedures; Injury; Intervention; Liquid substance; Magnetic Resonance Imaging; Medical; Methods; Modeling; Monitor; Mucous body substance; Myocardial Infarction; Nasal turbinate bone structure; Nervous System Physiology; Neurologic; Neurological outcome; Nose; Outcome; Patients; Phase; Physiological; Physiological Processes; Process; Production; Program Development; Randomized Clinical Trials; Recovery; Regulation; Relative (related person); Resuscitation; Safety; Saline; Shivering; Staging; Structure of mucous membrane of nose; Surface; Survival Rate; System; Techniques; Temperature; Testing; Therapeutic; Thermography; Upper respiratory tract; Water; Work; base; conditioning; economic value; efficacy testing; evaporation; healthy volunteer; heat exchanger; human study; human subject; improved; induced hypothermia; natural hypothermia; novel; novel strategies; pressure; programs; prototype; response; safety testing; vapor; vasoconstriction

DESCRIPTION (provided by applicant): This project will introduce a completely new approach for inducing mild hypothermia and cerebral cooling. Therapeutic Hypothermia (TH) has previously been shown to improve patient survival and neurological outcomes, but it has only been adopted by a small fraction of medical healthcare systems. The lack of adoption has, in part, been due to poor implementation methods that are either impractical, ineffective, or they interfere with EMS resuscitation efforts. This project will test and demonstrate a novel trans-nasal evaporative cooling device that solves these issues, which will facilitate a broader level of adoption and use of the therapy. Current induction techniques rely on some form of active cooling, whether by ice packs, cold saline or evaporative fluids. Our approach is novel in that we are harnessing a physiologic process that triggers the body to cool itself. There are no active cooling systems or evaporative chemicals. Our cooling method uses only dry, ambient air. The upper respiratory tract is very efficient at conditioning inspired air (prior to arrival at the luns), i.e., it can humidify dry air to full saturation very quickly. This humidifying process requires energy to convert water in the body to a vapor that is then mixed with the incoming dry air. Our cooling approach uses this physiological response to achieve the desired hypothermia. We force dry air through the nasal track and then extract the moisturized air, which effectively pulls energy and heat out of the body. This project will be completed in several sequential stages. In Phase I, we will build on our preliminary studies with pigs to optimize the cooling process variables, looking at a range of air flows and temperature. We will also develop a simple prototype device to deliver the therapy and to confirm the safety of the method. In Phase II, we will develop a clinical-grade device and perform additional pig studies to confirm that the induced hypothermia is safe, effective and is associated with improved outcome of resuscitation and short term neurologic function. We will end Phase II with a small human study to evaluate the safety, tolerability and efficacy of the process in humans. This work will validate a new method for inducing hypothermia that can be easily deployed during treatment of out-of-hospital cardiac arrest, as well as other ischemic injuries to the brain and the heart. We plan to continue our development program into larger clinical trials (post Phase II) to assess clinical benefits associated with introducing this therapy early after ROSC. Ultimately, we plan to leverage this grant program into the creation of a new product and therapy model that will have significant clinical and economic value.

描述（由申请人提供）：该项目将引入一种全新的方法来诱导轻度低温和脑冷却。低温治疗 (TH) 此前已被证明可以改善患者的生存率和神经系统结果，但仅被一小部分医疗保健系统采用。缺乏采用的部分原因是实施方法不佳，这些方法要么不切实际、无效，要么干扰 EMS 复苏工作。该项目将测试和演示一种新型经鼻蒸发冷却装置，该装置可以解决这些问题，这将促进更广泛的水平 采用和使用该疗法。目前的感应技术依赖于某种形式的主动冷却，无论是通过冰袋、冷盐水还是蒸发液体。我们的方法很新颖，因为我们正在利用一种生理过程来触发身体自我冷却。没有主动冷却系统或蒸发化学品。我们的冷却方法仅使用干燥的环境空气。上呼吸道在调节吸入空气（在到达肺部之前）方面非常有效，即它可以非常快速地将干燥空气加湿至完全饱和。这种加湿过程需要能量将体内的水转化为蒸气，然后与进入的干燥空气混合。我们的冷却方法利用这种生理反应来实现所需的低温。我们迫使干燥的空气通过鼻道，然后提取湿润的空气，从而有效地拉动 能量和热量排出体外。该项目将分几个连续阶段完成。在第一阶段，我们将在对猪的初步研究的基础上，研究一系列气流和温度，以优化冷却过程变量。我们还将开发一种简单的原型设备来提供治疗并确认该方法的安全性。在第二阶段，我们将开发一种临床级设备并进行额外的猪研究，以确认诱导低温是安全、有效的，并且与复苏结果和短期神经功能的改善相关。我们将通过一项小型人体研究来结束第二阶段，以评估该过程在人类中的安全性、耐受性和有效性。这项工作将验证一种诱导低温的新方法，该方法可以在院外心脏骤停以及其他大脑和心脏缺血性损伤的治疗过程中轻松使用。我们计划继续我们的开发计划进入更大规模的临床试验（第二阶段后），以评估与 ROSC 后早期引入这种疗法相关的临床益处。最终，我们计划利用这一资助计划来创建具有重大临床和经济价值的新产品和治疗模型。