Pandemic or Mass Casualty Aseptic Shared Ventilation

流行病或大规模伤亡的无菌共用通风

• 批准号: 7984140
• 负责人: Charles Kenton Akers
• 金额: $ 44.68万
• 依托单位: MEDICAL CONSERVATION DEVICES, LLC
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-17 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7984140
• 关键词: Aerosols; Air; Automation; Avian Influenza; Breathing; Centers for Disease Control and Prevention (U.S.); Certification; Cessation of life; Characteristics; Development; Devices; Engineering; Environment; Environmental air flow; Ethical Issues; Evaluation; Event; FDA approved; Flu virus; Foundations; Funding; Gases; Goals; Government; Guidelines; Health; Health Personnel; Healthcare; Healthcare Systems; Hospitals; Human; Individual; Infection Control; Influenza A Virus, H5N1 Subtype; International; Laboratories; Left; Marketing; Mechanical Ventilators; Mechanical ventilation; Medical; Medical Device; Mutate; New York; Notification; Outcome; Output; Oxygen; Patient Admission; Patients; Performance; Phase; Phase Transition; Positive-Pressure Respiration; Production; Resources; Small Business Innovation Research Grant; Solutions; Source; System; Technology; Testing; Tidal Volume; Time; United States; United States Food and Drug Administration; Update; Validation; Ventilator; base; commercialization; cost; cost effective; design; evaluation/testing; flu; innovation; meetings; next generation; operation; pandemic disease; prevent; product development; prototype; public health relevance; respiratory; simulation; technology development; transmission process

DESCRIPTION (provided by applicant): The CDC's FluSurge simulation shows that there will be a shortage of ventilators within the United States when the H5N1 flu virus mutates to airborne human-to-human transmission and the pandemic arrives. In the United States, it is estimated that nearly 85% of the 105,000 ventilators are in use at any time resulting, leaving in than 16,000 available to respond to a flu attack. However, for the suspected moderate to severe H5N1 Avian flu scenario, the need would be for over 65,000-742,500 ventilators conservatively costing $500 million to $6.2 billion to procure. Shared ventilation is a fundamentally unique approach which breaks the boundaries of current 1 ventilator to 1 patient mindset. The proposed project is to demonstrate and commercialize a next generation, largely disposable ventilator systems, which in its initial form, can use virtually any available ventilator and can provide ventilation for up to 6-8 patients without worries about cross contamination. In addition, each patient is provided individualized respiratory settings, including: oxygen concentration (Fi02), tidal volume and minute ventilation, and positive end expiratory pressure (PEEP). Furthermore, the system would significantly conserves oxygen, an equally scarce resource during pandemics, and cost ~1/3rd of any available alternative. Filing a 510k submission to the Food & Drug Administration is the final deliverable of this Phase I/II proposal. PUBLIC HEALTH RELEVANCE: The Centers for Disease Control's (CDC) FluSurge simulation of likely pandemic scenarios highlights a nationwide shortage of more than 725,000 ventilators. In New York State alone, over 100,000 deaths are forecasted to be directly and indirectly caused by this lack of ventilators leading The New York State Department of Health to study the medical and ethical issues of ventilator rationing as the only solution. Medical Conservation Devices (MCD) provides an innovative approach to resolve two major shortages (ventilator availability and oxygen supply) anticipated during a pandemic scenario by making it possible for one ventilator to support multiple patients with individualized respiratory control without cross contamination.

描述（由申请人提供）：CDC 的 FluSurge 模拟显示，当 H5N1 流感病毒突变为空气人际传播且大流行到来时，美国境内将出现呼吸机短缺的情况。在美国，估计 105,000 台呼吸机中有近 85% 随时处于使用状态，因此剩下超过 16,000 台呼吸机可用于应对流感发作。然而，对于疑似中度至重度 H5N1 禽流感的情况，需要 采购超过 65,000-742,500 台呼吸机，保守估计成本为 5 亿至 62 亿美元。 共享通气是一种根本上独特的方法，它打破了当前 1 台呼吸机对应 1 名患者的思维模式。拟议项目旨在演示下一代一次性呼吸机系统并将其商业化，该系统在其初始形式下几乎可以使用任何可用的呼吸机，并且可以为多达 6-8 名患者提供通气，而无需担心交叉污染。此外，还为每位患者提供个性化的呼吸设置，包括：氧浓度 (FiO2)、潮气量和每分钟通气量以及呼气末正压 (PEEP)。此外，该系统将显着节省氧气，而氧气是大流行期间同样稀缺的资源，并且成本约为任何可用替代方案的 1/3。向美国食品药品监督管理局提交 510k 申请是该 I/II 阶段提案的最终交付成果。公共卫生相关性：疾病控制中心 (CDC) FluSurge 对可能的大流行情景的模拟突显出全国范围内呼吸机短缺超过 725,000 台。仅在纽约州，预计就会有超过 100,000 人因缺乏呼吸机而直接或间接死亡，纽约州卫生部因此开始研究呼吸机配给的医疗和伦理问题，将其作为唯一的解决方案。医疗保护设备 (MCD) 提供了一种创新方法，使一台呼吸机能够在不交叉污染的情况下通过个性化呼吸控制来支持多名患者，从而解决大流行期间预期的两个主要短缺问题（呼吸机可用性和氧气供应）。