Rapid Induction of Therapeutic Hypothermia

快速诱导治疗性低温

• 批准号: 8627980
• 负责人: BENJAMIN R LANE
• 金额: $ 56.39万
• 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 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8627980
• 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，用于诱导温和的体温过低和大脑冷却。先前已证明治疗性体温过低（TH）可以改善患者的生存和神经系统效果，但仅由一小部分医疗保健系统采用。缺乏收养的部分原因是实施方法不当，不切实际，无效，或者它们干扰了EMS复苏工作。该项目将测试并展示一种新型的鼻蒸发冷却装置，以解决这些问题，这将有助于更广泛的水平 采用和使用该疗法。当前的诱导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。我们的方法是新颖的，因为我们正在利用一个生理过程，该过程触发身体以冷却自身。没有主动冷却系统或蒸发化学物质。我们的冷却方法仅使用干燥的环境空气。上呼吸道在调节启发的空气方面非常有效（在到达LUN之前），即，它可以很快将干燥的空气加湿至充分饱和。这种加湿的过程需要能量将体内的水转换为蒸气，然后将其与传入的干空气混合。我们的冷却方法使用这种生理反应来达到所需的体温过低。我们将干燥的空气穿过鼻轨道，然后提取保湿空气，这有效拉动 能量和热量从体内发出。该项目将在几个顺序阶段完成。在第一阶段，我们将以猪的初步研究为基础，以优化冷却过程变量，以查看一系列空气流和温度。我们还将开发一个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，我们将开发临床级装置，并进行其他猪研究，以确认诱导的体温过低是安全，有效的，并且与复苏结果的改善和短期神经系统功能有关。我们将通过一项小型人类研究结束II阶段，以评估人类过程的安全性，耐受性和功效。这项工作将验证一种诱发体温过低的新方法，该方法可以在医院外心脏骤停治疗期间很容易部署，以及大脑和心脏的其他缺血性损伤。我们计划将开发计划继续进行大型临床试验（第二阶段），以评估与ROSC早期引入该疗法有关的临床益处。最终，我们计划利用该赠款计划的创建新产品和治疗模型，该模型将具有巨大的临床和经济价值。