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.

每年约有300万新生儿死于早产、产时相关疾病、 条件和感染，呼吸窘迫是新生儿经历的严重条件 在每一种情况下都是如此。治疗呼吸窘迫的常见疗法是通过向患者提供富氧空气。 使用持续气道正压通气（CPAP）设备对新生儿进行治疗。这些设备的常见配置 包括将设备连接到新生儿上游的医用级氧气和空气罐， 使用混合器控制氧含量，该混合器还控制富氧空气的流速。的压力 下游连接有带吸管的发电水瓶，使新生儿逆压呼气 由吸管插入的水深限定，从而使肺膨胀并提供不受阻碍的 呼吸当前商业CPAP装置存在两个限制。首先，它们旨在要求 墙电来操作传感器和加湿器，这阻止了在院前和院内的治疗。 医院运输。第二，缺乏医疗级空气，特别是在资源贫乏地区 导致提供100%氧气的简易装置， 早产儿视网膜病变和支气管肺发育不良等并发症。在本提案中，我们 假设具有远程监控能力并输送 在宽范围的FIO 2上的富氧空气将使得气泡CPAP装置能够是便携式的，同时还 与市售的CPAP装置一起有效地起作用。正如我们的试点数据显示， 氧气可以在临床相关的流速下以受控的方式在宽的FIO 2范围内变化。我们 利用这些数据发明了一种配备有下游FIO 2传感器的通用环境空气-氧气混合器， 流量计，允许医疗保健提供者控制FIO 2和流量，而不管CPAP如何， 它是连接的。具体目的是：首先，检验一个普遍的环境空气-氧气 具有远程监控能力的搅拌器将使得气泡-CPAP装置能够通过设计而便携， 制造和测试原型气泡CPAP装置;第二，为了测试环境空气- 当模块与市售CPAP集成时，氧气混合器将有效地发挥作用 目前依赖于医用级氧气和空气罐的系统。成功完成该项目 将提供便携式CPAP装置，用于运输以及医院病床使用，允许环境 空气-氧气混合器与其他CPAP设备，使得无需改进设备以提供100% 氧气，可导致器官损伤，并使远程监测，以确保顺利运作的 设备.