A universal ambient air-oxygen blender to treat respiratory distress in newborns

用于治疗新生儿呼吸窘迫的通用环境空气氧气混合器

• 批准号: 10384958
• 负责人: Bruce Lawrence Carvalho
• 金额: $ 16.56万
• 依托单位: POLYMERIX LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10384958
• 关键词: Adult; Air; Bronchopulmonary Dysplasia; Caring; Complication; Continuous Positive Airway Pressure; Data; Delivery Rooms; Devices; Electricity; Ensure; Exhalation; Far East; Health Personnel; Hospitals; Humidifier; Incidence; India; Infant; Infection; International; Legal patent; Lung; Mechanical Ventilators; Medical; Medical Device; Newborn Infant; Organ; Oxygen; Research; Resistance; Resource-limited setting; Respiration; Respiratory distress; Resuscitation; Retinopathy of Prematurity; Stream; System; Technology; Testing; Water; Work; clinically relevant; common treatment; design; effective therapy; experience; hospital bed; interest; intrapartum; neonatal death; neonate; oxygen toxicity; portability; premature; pressure; prevent; prototype; remote monitoring; respiratory; sensor

Approximately 3 million neonatal deaths occur annually due to prematurity, intra-partum related conditions and infections, with respiratory distress being a serious condition being experienced by the newborn in each case. A common treatment to treat respiratory distress is by providing oxygen-enriched air to the neonate using a continuous positive airway pressure (CPAP) device. A common configuration of these devices involves connecting the device to a medical grade oxygen and air tanks upstream from the newborn to titrate the oxygen content using a blender, which also controls the flow rate of the oxygen-enriched air. A pressure generating water bottle with a straw is connected downstream so that the newborn exhales against pressure defined by the water depth to which the straw is inserted, thus inflating lungs and providing unimpeded respiration. There are two limitations of current commercial CPAP devices. First, they are designed to require wall electricity to operate the sensors and humidifier, which prevents treatment during pre-hospital and intra- hospital transport. Second, lack of availability of medical grade air especially in resource poor regions worldwide have led to improvised devices delivering 100% oxygen causing severe oxygen toxicity-related complications such as retinopathy of prematurity and bronchopulmonary dysplasia. In this proposal, we hypothesize that a universal ambient air-oxygen blender with remote monitoring capability and delivering oxygen-enriched air over a wide range of FIO2 will enable a bubble-CPAP device to be portable, while also functioning effectively with commercially-available CPAP devices. As our pilot data show, the percentage of oxygen can be varied over a wide range of FIO2 in a controlled manner at clinically relevant flow rates. We used this data to invent a universal ambient air-oxygen blender equipped with a downstream FIO2 sensor and flow rate gauge, allowing the healthcare provider to control FIO2 and flow rates, regardless of the CPAP to which it is connected. The Specific Aims are: first, to test the hypothesis that a universal ambient air-oxygen blender with remote monitoring capability will enable a bubble-CPAP device to be portable by designing, fabricating and testing a prototype bubble-CPAP device; second, to test the hypothesis that the ambient air- oxygen blender will functioning effectively when the module is integrated with commercially-available CPAP systems that currently rely on both medical grade oxygen and air tanks. Successful completion of this project will provide a portable CPAP device for transport as well as hospital bed use, allow integration of an ambient air-oxygen blender with other CPAP devices making it unnecessary to improvise devices to deliver 100% oxygen that can cause organ damage and enable remote monitoring to ensure smooth functioning of the device.

大约300万新生儿死亡每年由于早产，与伴有内部有关 疾病和感染，呼吸窘迫是新生儿经历的严重疾病 在每种情况下。治疗呼吸窘迫的一种常见治疗方法是通过向富含氧气的空气提供给 使用连续的正气道压力（CPAP）装置的新生儿。这些设备的常见配置 涉及将设备连接到新生儿上游的医疗级氧气和空气箱 使用搅拌器的氧气含量，该含量还控制富含氧气的空气的流速。压力 用稻草产生水瓶是下游连接的，因此新生儿呼气可抵抗压力 由插入吸管的水深度定义，从而使肺部充气并提供不受阻碍 呼吸。当前的商业CPAP设备有两个局限性。首先，它们被设计为需要 壁电力可操作传感器和加湿器，这阻止了院前和内部治疗 医院运输。其次，缺乏医疗级空气的可用性，尤其是在资源较差的地区 全球导致即兴设备提供100％的氧气，导致严重的氧气毒性与毒性有关 早产和支气管肺发育不良的视网膜病变等并发症。在这个建议中，我们 假设具有远程监控功能并提供的通用环境空气氧气搅拌器 富含氧气的空气在各种FiO2上都可以使Bubble-CPAP设备可移植，同时也可以 通过商业上可用的CPAP设备有效运行。正如我们的飞行员数据所示， 氧气可以在临床上相关的流速下以受控方式在广泛的FIO2上变化。我们 使用此数据来发明配备下游FiO2传感器的通用环境空气氧气搅拌器和 流速量规，允许医疗保健提供商控制FIO2和流量，而不管CPAP如何 它是连接的。具体目的是：首先，测试普遍环境空气氧的假设 具有远程监视功能的搅拌器将使Bubble-CPAP设备通过设计，可移植， 制造和测试原型气泡CPAP设备；其次，为了检验以下假设：环境空气 - 当模块与市售的CPAP集成时，氧气搅拌器将有效地发挥作用 目前依靠医疗级氧气和空气箱的系统。成功完成该项目 将提供一种便携式CPAP设备，用于运输以及医院的床，允许整合环境 带有其他CPAP设备的Air-Oxygen Blender，使即兴设备不需要提供100％的设备 可能导致器官损坏并实现远程监控的氧气，以确保平稳运行 设备。