Pilot Human Study Using Transnasal Cooling on Cardiac Arrest Subjects

 描述(由申请人提供)：该项目将导致一种名为CoolStat的临床级产品的创建，该产品将能够在心脏骤停后快速安全地冷却大脑和身体。CoolStat旨在由EMS人员启动，以便在心跳骤停后开始早期降温，这已被证明可以提高存活率和神经预后。作为整个项目的一部分，我们将(1)创建临床级别的CoolStat产品用于人体试验；(2)获得FDA批准，将该产品用于心脏骤停试验性研究(通过IDE)；以及(3)完成对心脏骤停患者的试验性研究，以衡量安全性和降温效果。目前为患者提供早期降温的技术并不有效，依赖于某种形式的主动降温，无论是通过冰袋、冷盐水还是蒸发液体。我们的方法是新颖的，因为我们正在利用一个生理过程，触发身体自我降温。没有活动的冷却系统或蒸发的化学物质。我们的降温方法只使用干燥的环境空气，我们将这些空气吹入鼻道，然后从口腔中抽出潮湿的空气。这建立了一种蒸发冷却热交换，它有效地将能量和热量吸出体外，在10分钟内以大约1摄氏度的速度冷却大脑。这个项目将 是我们之前完成的赠款工作的延伸，包括临床前和人体可行性测试。我们将分三个阶段完成这个拟议的项目。在第一年，我们将从该产品的台式原型过渡到制造约50个临床级设备。我们还将从FDA获得一个集成开发环境来运行这项人体研究。在第二年，我们将通过与我们的战略合作伙伴Zoll Medical合作来实施人体研究，Zoll Medical是患者体温管理领域的领先商业公司。Zoll已同意与我们合作，使他们能够更好地评估我们的冷却技术的好处。试探性地，这项人体研究将在Zoll预先批准的5个地点进行。在第三年，我们将完成人体研究，分析并发布结果，并有望过渡到与Zoll的关键研究。这项工作将验证一种新的诱导低温的方法，这种方法可以很容易地在院外心脏骤停以及其他脑和心脏缺血性损伤的治疗中部署。它将证明早期降温的临床价值，并有望成为护理的标准。最终，我们计划利用这一赠款计划创建一系列降温产品，可用于心脏骤停、ST段抬高的心肌梗死、中风和其他潜在的适应症。

 DESCRIPTION (provided by applicant): This project will result in the creation of a clinical-grade product called the CoolStat that will be able to quickly and safely cool the brain and body after cardiac arrest. The CoolStat is designed to be initiated by EMS personnel to start early cooling post arrest, which has been shown to improve survival rates and neurological outcomes. As part of this overall project, we will (1) create the clinical-grade CoolStat product for use in human trial; (2) obtain FDA approval to use the product in a pilot cardiac arrest study (via an IDE); and (3) complete the pilot study in cardiac arrest victims to measure safety and cooling efficacy. Current techniques to provide early cooling to patients are not effective, relying 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 that we blow into the nasal track and then extract the moisturized air from the mouth. This sets up an evaporating cooling heat exchange, which effectively pulls energy and heat out of the body, cooling the brain at a rate of about 1 C in 10 minutes. This project will be an extension of previous grant work we have completed, including pre-clinical and feasibility testing in humans. We will complete this proposed project in three sequential stages. In Year 1, we will transition from a bench-top prototype of the product to making about 50 clinical-grade devices. We will also obtain an IDE from the FDA to run the human study. In Year 2, we will implement the human study by working with our strategic partner, Zoll Medical, a leading commercial company in the field of patient temperature management. Zoll has agreed to partner with us to allow them to better assess the benefit of our cooling technology. Tentatively, the human study will be conducted at 5 sites that have been pre-approved by Zoll. In Year 3, we will finish the human study, analyze and publish the results, and hopefully transition into a pivotal study with Zoll. 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. It will prove the clinical value of early cooling and hopefully become a standard of care. Ultimately, we plan to leverage this grant program into the creation of a family of cooling products that can be used for cardiac arrest, ST elevated myocardial infarction, stroke and other potential indications.