Pilot Human Study Using Transnasal Cooling on Cardiac Arrest Subjects

对心脏骤停受试者使用经鼻冷却的试点人体研究

• 批准号: 9254592
• 负责人: BENJAMIN R LANE
• 金额: $ 85.15万
• 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 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9254592
• 关键词: Adverse effects; Air; Animals; Blood Circulation; Brain; Brain Injuries; Cardiac; Cause of Death; Cerebral Ischemia; Chemicals; Clinical; Clinical Trials; Clinical Trials Design; Data; Developing Countries; Device Designs; Device or Instrument Development; Devices; Disease; Enrollment; Ensure; Family; Goals; Grant; Heart; Heart Arrest; Hospitals; Human; Human Resources; Ice; Injury; Institutes; Ischemia; Liquid substance; Measures; Medical; Medical Device; Methods; Myocardial Infarction; Nasopharynx; Neurological outcome; Nose; Oral cavity; Organ; Patients; Performance; Physiological Processes; Pilot Projects; Process; Publishing; Reperfusion Therapy; Research Design; Research Infrastructure; Resuscitation; Risk; Running; Safety; Saline; Site; Small Business Innovation Research Grant; Stroke; Survival Rate; System; Techniques; Technology; Temperature; Testing; Therapeutic; Therapeutic Uses; Traumatic Brain Injury; Untrained Personnel; Work; animal data; commercialization; design; experience; human study; human subject; improved; induced hypothermia; interest; mortality; natural hypothermia; novel; pilot trial; pre-clinical; programs; prototype; public health relevance; safety study; standard of care; survival outcome

 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.

 描述（由申请人提供）：该项目将创建一种名为 CoolStat 的临床级产品，该产品能够在心脏骤停后快速安全地冷却大脑和身体。 CoolStat 设计为由 EMS 人员启动。逮捕后开始早期降温，这已被证明可以提高存活率和神经学结果，作为整个项目的一部分，我们将 (1) 创建用于人体试验的临床级 CoolStat 产品；(2) 获得 FDA 批准；使用该产品心脏骤停试点研究（通过 IDE）；（3）完成心脏骤停患者的试点研究，以衡量安全性和冷却效果，无论是否依靠某种形式的主动冷却，目前为患者提供早期冷却的技术都是无效的。我们的方法很新颖，因为我们利用了一种触发身体自我冷却的生理过程。我们的冷却方法仅使用干燥的环境空气。我们吹入鼻道，然后从口腔中提取湿润的空气，这会建立一个蒸发冷却热交换，有效地将能量和热量排出体外，从而在 10 分钟内以约 1°C 的速度冷却大脑。 是我们之前完成的资助工作的延伸，包括临床前和人体可行性测试，我们将分三个连续阶段完成这个拟议的项目，我们将从产品的台式原型过渡到制造。我们还将从 FDA 获得约 50 种临床级设备来进行人体研究。在第二年，我们将与我们的战略合作伙伴 Zoll Medical（一家领先的商业公司）合作实施人体研究。 Zoll 已同意进行患者体温管理。与我们合作，让他们更好地评估我们的冷却技术的好处，人体研究将在 Zoll 预先批准的 5 个地点进行。在第 3 年，我们将完成人体研究、分析和发布。研究结果有望转化为与 Zoll 合作的关键研究，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脑部和脑部缺血性损伤的治疗过程中轻松使用。心。将证明早期降温的临床价值，并有望成为护理标准，最终，我们计划利用这一资助计划创建一系列降温产品，可用于心脏骤停、ST 升高的心肌梗死、中风等。潜在的迹象。

项目成果

Efficacy and Safety of Transnasal CoolStat Cooling Device to Induce and Maintain Hypothermia.

经鼻 CoolStat 冷却装置诱导和维持低温的功效和安全性。

• 发表时间: 2019-06
• 作者: Assis, Fabrizio R;Bigelow, M Emma G;Chava, Raghuram;Sidhu, Sunjeet;Kolandaivelu, Aravindan;Halperin, Henry;Tandri, Harikrishna
• 通讯作者: Tandri, Harikrishna