背景:尽管医院内外都需要机械通气,在许多情况下,由于成本或尺寸限制,机械呼吸机仍然无法使用。机械通气在创伤情况下尤其重要,但是标准机械呼吸机不切实际的尺寸和重量限制了急救人员将它们装在医疗援助袋中,导致依赖不精确的手动袋面罩通风。这在与战斗有关的伤害中尤为重要,气道受损和呼吸衰竭是可预防死亡的主要原因,但是医生没有必要的机械通气。为了解决机械通风可及性方面的严重差距,我们正在发展自治,模块化,和便携式通风平台(AMP-Vent)适用于严峻的环境,长期重症监护,外科应用,大规模伤亡事件,和储存。核心系统非常紧凑,重量<2.3公斤,可以放在鞋盒里(23.4厘米×17.8厘米×10.7厘米)。值得注意的是,该设备比标准运输呼吸机轻65%,比典型的重症监护病房呼吸机轻96%。除了其出色的便携性,AMP-Vent的制造成本不到传统呼吸机的十分之一。尽管它的尺寸和成本都降低了,系统的功能是不妥协的。核心系统配备了闭环传感器和先进的通风模式(压力控制,音量控制,和同步间歇强制通风),在便携式外形中实现优质护理。目前的原型已经通过使用呼吸模拟器(ASL5000)和大型动物模型(猪)的试验进行了初步的临床前测试和优化。本报告旨在介绍一种新颖的通气系统,并通过从临床前研究中收集的证据来证实其有希望的性能。
方法:根据ISO80601-2-12:2020的表201.105“压力控制充气类型测试”,使用ASL5000进行肺部模拟器测试。在模拟之后,在健康的10千克雌性家养仔猪中测试了AMP-Vent。费城儿童医院动物护理和使用委员会批准了所有动物程序。猪接受了4分钟的交替通风,其中AMP-Vent和常规麻醉呼吸机(GEAISYSCS2)用于滴定不同的潮气末二氧化碳(EtCO2)目标,每个上升目标(35、40、45、50、55mmHg)的初始呼吸机切换。
结果:在ASL5000模拟期间,AMP-Vent在不同条件下表现出一致的性能,在每个测试中保持2%或更小的变异系数。在一项大型动物研究中,AMP-Vent维持了EtCO2和SpO2目标,其性能与常规麻醉呼吸机(GEAISYSCS2)相当。此外,在几个EtCO2目标(35,40,45,50和55mmHg)下,常规麻醉呼吸机和AMP-Vent之间的分钟通气量(Ve)分布的比较未发现有统计学意义的差异(使用Kruskal-Wallis秩和检验,p=0.46).
结论:本研究的临床前结果突出了AMP-Vent的核心功能和在不同情况下的一致性能。AMP-Vent以其非常紧凑的设计为便携性设定了基准,将其定位为在以前无法进入的医疗场景中彻底改变创伤护理。
BACKGROUND: Despite the significant need for mechanical ventilation in- and out-of-hospital, mechanical ventilators remain inaccessible in many instances because of cost or size constraints. Mechanical ventilation is especially critical in trauma scenarios, but the impractical size and weight of standard mechanical ventilators restrict first responders from carrying them in medical aid bags, leading to reliance on imprecise manual bag-mask ventilation. This is particularly important in combat-related injury, where airway compromise and respiratory failure are leading causes of preventable death, but medics are left without necessary mechanical ventilation. To address the serious gaps in mechanical ventilation accessibility, we are developing an Autonomous, Modular, and Portable Ventilation platform (AMP-Vent) suitable for austere environments, prolonged critical care, surgical applications, mass casualty incidents, and stockpiling. The core system is remarkably compact, weighing <2.3 kg, and can fit inside a shoebox (23.4 cm × 17.8 cm × 10.7 cm). Notably, this device is 65% lighter than standard transport ventilators and astoundingly 96% lighter than typical intensive care unit ventilators. Beyond its exceptional portability, AMP-Vent can be manufactured at less than one-tenth the cost of conventional ventilators. Despite its reduced size and cost, the system\'s functionality is uncompromised. The core system is equipped with closed-loop sensors and advanced modes of ventilation (pressure-control, volume-control, and synchronized intermittent mandatory ventilation), enabling quality care in a portable form factor. The current prototype has undergone preliminary preclinical testing and optimization through trials using a breathing simulator (ASL 5000) and in a large animal model (swine). This report aims to introduce a novel ventilation system and substantiate its promising performance through evidence gathered from preclinical studies.
METHODS: Lung simulator testing was performed using the ASL 5000, in accordance with table 201.105 \"pressure-control inflation-type testing\" from ISO 80601-2-12:2020. Following simulations, AMP-Vent was tested in healthy 10-kg female domestic piglets. The Children\'s Hospital of Philadelphia Institutional Animal Care and Use Committee approved all animal procedures. Swine received 4-min blocks of alternating ventilation, where AMP-Vent and a conventional anesthesia ventilator (GE AISYS CS2) were used to titrate to varied end-tidal carbon dioxide (EtCO2) goals with the initial ventilator switching for each ascending target (35, 40, 45, 50, 55 mmHg).
RESULTS: During ASL 5000 simulations, AMP-Vent exhibited consistent performance under varied conditions, maintaining a coefficient of variation of 2% or less within each test. In a large animal study, AMP-Vent maintained EtCO2 and SpO2 targets with comparable performance to a conventional anesthesia ventilator (GE AISYS CS2). Furthermore, the comparison of minute ventilation (Ve) distributions between the conventional anesthesia ventilator and AMP-Vent at several EtCO2 goals (35, 40, 45, 50, and 55 mmHg) revealed no statistically significant differences (p = 0.46 using the Kruskal-Wallis rank sum test).
CONCLUSIONS: Preclinical results from this study highlight AMP-Vent\'s core functionality and consistent performance across varied scenarios. AMP-Vent sets a benchmark for portability with its remarkably compact design, positioning it to revolutionize trauma care in previously inaccessible medical scenarios.