Name: a novel inhalation mask system to deliver high concentrations of nitric oxide gas in spontaneously breathing subjects
Uploaded: 2021-05-04T13:00:00
Description: Watch this Scientific Journal Video about A Novel Inhalation Mask System to Deliver High Concentrations of Nitric Oxide Gas in Spontaneously Breathing Subjects at JoVE.com

这项研究得到了哈佛医学院雷金纳德·詹尼捐赠主席对L.B的支持，得到了L.B医学部的杂物基金的支持，以及MGH麻醉、重症监护和疼痛医学部麻醉中心重症监护研究中心的实验室基金的支持。

注：请参阅组装交付系统所需的材料材料表。医疗空气、O2和无气体的来源也应在现场提供。该装置已开发用于研究协议中的调查，并经过当地机构审查委员会（IRB）的严格审查。在任何情况下，提供商都不应仅根据本手稿中包含的指示进行运营，在未事先获得适当机构监管批准的情况下组装和使用此设备。从设备的近端开始，按以下顺序组装件件（图1）。</s...

<ol>
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鉴于对无管注射患者（包括COVID-198患者）的无气体治疗的兴趣日益浓厚，本报告描述了一种新型的定制设备，以及如何组装其组件，以高达250ppm的浓度提供NO。拟议的系统由廉价的消耗品构建，并安全地在自发呼吸的患者中提供可重复浓度的无气体。组装和使用的便利性，加上其他地方公布的安全数据16，17，使该系统的理想体现，以管理高无气体浓度在不同的F...

在几个临床环境中，没有吸入疗法经常被用作救命疗法。。。除了其众所周知的肺吸附剂效应4外，NO还对细菌5、病毒6和真菌7表现出广泛的抗菌作用，特别是在高浓度（>100ppm）下施用。8在二零零三年严重急性呼吸系统综合症（SARS）爆发期间，NO在体外显示有效的抗病毒活性，并显示感染SARS-科罗纳病毒（SARS-CoV）9、10的病人有疗效。2003年病毒株在结构上与SARS-Cov-2相似，SARS-Cov-2是导致目前冠状病毒性疾病-2019（COVID-19）大流行11的病原体。在COVID-19患者中，正在进行三项随机对照临床试验，以确定呼吸高浓度无气体的潜在益处，以改善结果12、13、14。在第四项正在进行的研究中，正在研究高浓度NO的预防吸入，作为预防接触SARS-CoV-2阳性患者的卫生保健提供者COVID-19发展的预防措施。
为COVID-19开发有效和安全的治疗是医疗保健和科学界的优先事项。为了调查非受管患者和志愿医护人员的剂量>80ppm的无毒气体的施用情况，开发一个安全可靠的非侵入性系统的必要性变得显而易见。这项技术旨在对自发呼吸的受试者管理不同成分的受启发氧（FiO2）的高无浓度。这里描述的方法目前用于研究目的，在马萨诸塞州总医院（MGH）16，17自发呼吸COVID-19患者。根据MGH人类研究伦理委员会的指导方针，目前建议的系统用于进行一系列随机对照试验，以研究高浓度无气体的以下影响。首先，在轻度COVID-19的非受管受试者中，正在研究160ppm无气体的影响，该受试者要么在急诊部（IRB协议#2020P001036）14中被录取，要么作为住院病人（IRB协议#2020P000786）18。第二，正在审查高剂量NO的作用，以防止SARS-CoV-2感染和COVID-19症状的发展，在卫生保健提供者经常暴露在SARS-CoV-2阳性患者（IRB协议#2020P000831）19。
这种简单的设备可以组装与标准耗材，通常用于呼吸治疗。拟议的仪器旨在非侵入性地提供无气体、医用空气和氧气（O2）的混合物。将二氧化氮（NO2）吸入降至最低，以降低气道毒性的风险。美国政府工业卫生会议设定的当前 NO2 安全阈值比 8 小时时间加权平均值高 3 ppm，5 ppm 是短期暴露限制。相反，国家职业安全与健康研究所建议将1ppm作为短期接触限制20。鉴于人们对高剂量无毒气体疗法的兴趣日益浓厚，本报告对这种新设备作了必要的描述。它解释了如何组装其组件，以提供高浓度的 NO 用于研究目的。

<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>90&#176; ventilator elbow connector without ports 22 mm ID x 22 mm OD</td>
			<td>Teleflex, Wayne, PA, USA</td>
			<td>1641</td>
			<td></td>
		</tr>
		<tr>
			<td>Aerosol tee connector: horizontal ports 22 mm OD, vertical port 11 mm ID/22 mm OD</td>
			<td>Teleflex, Wayne, PA, USA</td>
			<td>1077</td>
			<td></td>
		</tr>
		<tr>
			<td>Flexible patient connector for endotracheal or tracheostomy tube (15 mm OD x 22 mm OD/15 mm ID, length 5 cm to 6.5 cm)</td>
			<td>Vyaire Medical Inc., Mettawa, IL, USA</td>
			<td>3215</td>
			<td></td>
		</tr>
		<tr>
			<td>High-efficiency particulate air (highly hydrophobic bacterial/viral filter,&#160; HEPA class 13) filter (22 mm ID/15 mm OD x 22 mm OD/15 mm ID connector)</td>
			<td>Teleflex, Wayne, PA, USA</td>
			<td>28012</td>
			<td></td>
		</tr>
		<tr>
			<td>Latex-free 3-L breathing reservoir bag</td>
			<td>CareFusion, Yorba Linda, CA, USA</td>
			<td>5063NL</td>
			<td></td>
		</tr>
		<tr>
			<td>Nitric Oxide tank 800 ppm medical-grade (size AQ aluminum cylinders containing 2239 L at STP of 800 ppm NO gas balanced with nitrogen, volume 2197 L)</td>
			<td>Praxair, Bethlehem PA, USA</td>
			<td>MM NO800NI-AQ</td>
			<td></td>
		</tr>
		<tr>
			<td>One-way valve 22 mm male/female (arrow pointing towards female end)</td>
			<td>Teleflex, Wayne, PA, USA</td>
			<td>1664</td>
			<td>N=2 inspiratory limb (upward arrow)</td>
		</tr>
		<tr>
			<td>One-way valve 22 mm male/female (arrow pointing towards male end)</td>
			<td>Teleflex, Wayne, PA, USA</td>
			<td>1665</td>
			<td>N=1 expiratory limb (downward arrow)</td>
		</tr>
		<tr>
			<td>Rad-57 Handheld Pulse Oximeter with Rainbow SET Technology</td>
			<td>Masimo Corporation, Irvine, CA, USA</td>
			<td>3736</td>
			<td>Including SpMet Option</td>
		</tr>
		<tr>
			<td>Scavenger (ID = 60 mm, internal length = 53 mm, volume = 150 mL) containing 100 g of calcium hydroxide</td>
			<td>Spherasorb, Intersurgical Ltd, Berkshire, UK</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Silicon rubber flexible connectors 22 mm F x 22 mm F</td>
			<td>Tri-anim Health Services, Dublin, OH, USA</td>
			<td>301-9000</td>
			<td></td>
		</tr>
		<tr>
			<td>Snug-fit standard face mask of appropriate size</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Star Lumen standard medical grade vynil oxygen tubing with universal connectors</td>
			<td>Teleflex, Morrisville, NC, USA</td>
			<td>1115</td>
			<td>Variable length according to distance from source of gas. 2.1 m length used in protocol</td>
		</tr>
		<tr>
			<td>Straight connector with a 7.6 mm sampling port (15 mm OD x 15 mm ID/22 mm OD)</td>
			<td>Mallinckrodt, Bedminster, NJ, USA</td>
			<td>502041</td>
			<td></td>
		</tr>
		<tr>
			<td>Two-step adapter (15 mm to 22 mm)</td>
			<td>Airlife Auburndale, FL, USA</td>
			<td>1824</td>
			<td></td>
		</tr>
		<tr>
			<td>Y-piece connector with 7.6 mm ports (22 mm to 22 mm and 15 F)</td>
			<td>Vyaire Medical Inc., Mettawa, IL, USA</td>
			<td>1831</td>
			<td></td>
		</tr>
	</tbody>
</table>

a novel inhalation mask system to deliver high concentrations of nitric oxide gas in spontaneously breathing subjects

一氧化氮（NO）被作为吸入气体管理，以诱导选择性肺血管化。这是一种安全的治疗方法，即使高浓度地进行治疗，也几乎没有潜在的风险。吸入的无气体通常用于在不同的疾病条件下增加全身氧合。高浓度NO的管理在体外也起到恶毒的作用。由于其有利的药理动力学和安全配置文件，关键护理提供者熟悉其使用情况，以及潜在的直接病毒效应，NO临床上用于冠状病毒性疾病-2019（COVID-19）患者。然而，目前没有设备能够轻松地在各种受启发的氧气分数中浓度超过百万分之 80（ppm）的浓度下轻松管理吸入的 NO，而不需要专用、重型和昂贵的设备。开发可靠、安全、廉价、轻便和无呼吸机的解决方案至关重要，特别是对于在重症监护室 （ICU） 之外和资源有限的情况下对非受管患者进行早期治疗至关重要。为了克服这一障碍，利用标准耗材和清扫室开发了一个非侵入性无气管理系统，最高可达 250 ppm。该方法已被证明在降低二氧化氮含量的同时，在提供指定的无浓度方面是安全可靠的。本文旨在为临床医生和研究人员提供必要的信息，说明如何组装或调整该系统，用于研究目的或在COVID-19或其他疾病中临床使用，而无管理可能有益。

一名33岁的呼吸治疗师在MGHICU工作期间，ICU的COVID-19的入院人数激增，自愿接受NO，作为涉及15，19名医护人员的试验的一部分。试验测试了160ppm的NO作为毒剂的疗效，从而防止了肺部疾病的发生，从而面临病毒污染的风险。吸入预防的第一个会话在开始通过描述的设备换班 15 分钟之前进行了管理。出于研究目的，连续测量吸入的N...

Watch this Scientific Journal Video about A Novel Inhalation Mask System to Deliver High Concentrations of Nitric Oxide Gas in Spontaneously Breathing Subjects at JoVE.com

A Novel Inhalation Mask System to Deliver High Concentrations of Nitric Oxide Gas in Spontaneously Breathing Subjects

这种简单且适应性强的系统设备用于吸入高浓度一氧化氮 （NO） 气体，不需要机械呼吸机、正压或高气体流动。标准医疗耗材和贴合面膜用于安全地向自发呼吸的受试者输送无气体。

一种新型吸入面膜系统，可在自发呼吸受试者中提供高浓度的一氧化氮气体

Nitric Oxide (NO) is administered as gas for inhalation to induce selective pulmonary vasodilation. It is a safe therapy, with few potential risks even if ...

吸入一氧化氮可以改善严重缺氧症患者的氧化。在高浓度下，一氧化氮具有广泛的抗菌作用。一些试验正在测试一氧化氮对COVID-19的影响。迄今为止，没有设备能够以高于百万分之80的浓度管理吸入的一氧化氮，而无需专用的重型和昂贵的设备。该设备将允许高剂量吸入一氧化氮在医院环境之外交付。由于多抗药性细菌而导致肺结肠化的患者，如囊性纤维化患者，将能够从这种治疗中受益。演示这个程序的将是斯特凡诺·吉安尼和比扬·萨法伊·法赫尔，两个来自我实验室的博士后研究员。要设置患者界面，通过 22 毫米外径 15 毫米内径连接器连接适合受试者的舒适安装标准非侵入性通风面罩的内置弯头端口，以便使用高效颗粒空气过滤器。要构建 Y 件，请使用两个相反的感觉，低阻力 22 毫米的男女单向阀门，在 22 毫米到 22 毫米的两端和 15 个具有 7.6 毫米端口的法国 Y 片连接器上创建过期和吸气四肢。将单向阀门连接器定位到到期肢体，箭头向下指向，仅允许近亲离心流动，并将连接器定位为吸气肢体，箭头向上指向，仅允许离心流到近流。然后使用 15 到 22 毫米的两步适配器将清理室和管子组件连接到 Y 件的吸气肢体上。准备清理室 将 22 乘 22 毫米柔性硅橡胶连接器适配器连接到包含 100 克氢氧化钙的清道夫室的近端，再连接 22 到 22 毫米柔性硅橡胶连接器适配器到清除器的外端，并使用标准的防扭结乙烯基气管，两端使用通用适配器将氧气源与吸气肢体连接起来。要准备一氧化氮储层系统，请将气溶胶 T 片连接到没有端口的 90 度呼吸机肘部连接器中，并将肘部的另一端连接到三升无乳胶呼吸储层袋。附加另一个单向吸气阀，箭头指向连续两个 15 毫米外径（外径 22 毫米，内径 15 毫米）连接器的远端，带 7.6 毫米采样端口和翻转 顶盖，将 15 到 22 毫米的两步适配器连接到系统的近端，并将近双步适配器与一氧化氮绿色 T 件的剩余免费入口连接水库系统。要连接空气和一氧化氮气体流线，使用标准的抗扭结星路门乙烯基氧管将医用气流与最远距离气体入口连接，并将一氧化氮气体从百万分之八百的医用级一氧化氮罐连接到下游的下一个港口。要将一氧化氮管理到自发呼吸的主体，请根据表设置空气、氧气和一氧化氮气体流，并将紧贴面罩放置在受试者脸上，类似于非侵入性通风接口设置。然后在所需的持续时间内开始吸入会话。可追踪一氧化氮和二氧化氮浓度，以评估处理过程中气体输送的稳定性。一名33岁的呼吸治疗师在ICU在大众总医院的ICU工作，在ICU为COVID-19的入院人数激增期间，自愿接受一氧化氮，作为涉及医护人员的试验的一部分。由此产生的一氧化氮浓度为百万分之160，总气体流量为每分钟19.5升，按每分钟流量计三个标准15升计算，在整个吸入期间保持稳定。二氧化氮达到百万分之0.77的峰值，因此安全低于建议的毒性阈值。安全地提供高浓度吸入一氧化氮的可能性为将这种疗法应用于其他疾病开辟了领域，其中一氧化氮可以成为有效的治疗方法。

Research

JoVE Journal

Medicine

Expired CO2 Measurement in Intubated or Spontaneously Breathing Patients from the Emergency Department

Expired CO2 Measurement in Intubated or Spontaneously Breathing Patients from the Emergency Department

过期的CO 2测量气管插管或自主呼吸的病人从急诊科

Carbon dioxide (CO2) along with oxygen (O2) share the role of being the most important gases in the human body. The measuring of expired CO2 at the mouth ...

科研

医学

Analytical Techniques for Assaying Nitric Oxide Bioactivity

为含量测定一氧化氮生物活性分析技术

Nitric oxide (NO) is a diatomic free radical that is extremely short lived in biological systems (less than 1 second in circulating blood)1. NO may be ...

Use of Animal Model of Sepsis to Evaluate Novel Herbal Therapies

脓毒症动物模型，用于评估新型草药疗法

Sepsis refers to a systemic inflammatory response syndrome resulting from a microbial infection. It has been routinely simulated in animals by several ...

Intraoperative Detection of Subtle Endometriosis: A Novel Paradigm for Detection and Treatment of Pelvic Pain Associated with the Loss of Peritoneal Integrity

术中的微妙的子宫内膜异位症的检测：A新型范式为相关联的与的的腹膜的完整性之亏损盆腔疼痛的的的的检测和治疗的

Endometriosis is a  common disease affecting 40 to 70% of reproductive-aged women with chronic  pelvic pain (CPP) and/or infertility. The purpose of this ...

A Novel High-resolution In vivo Imaging Technique to Study the Dynamic Response of Intracranial Structures to Tumor Growth and Therapeutics

A Novel High-resolution In vivo Imaging Technique to Study the Dynamic Response of Intracranial Structures to Tumor Growth and Therapeutics

一种新型的高分辨率<em&gt;在体内</em&gt;成像技术研究肿瘤生长及治疗颅内结构的动态响应

We have successfully integrated previously established Intracranial window (ICW) technology 1-4 with intravital 2-photon confocal microscopy to develop a ...

5/6th Nephrectomy in Combination with High Salt Diet and Nitric Oxide Synthase Inhibition to Induce Chronic Kidney Disease in the Lewis Rat

5/6th联合切除术，高盐饮食和一氧化氮合酶抑制剂诱导Lewis大鼠慢性肾脏病

Chronic kidney disease (CKD) is a global problem. Slowing CKD progression is a major health priority. Since CKD is characterized by complex derangements ...

Performing Subretinal Injections in Rodents to Deliver Retinal Pigment Epithelium Cells in Suspension

视网膜下进行注射的鼠害提供视网膜色素上皮细胞悬浮

The conversion of light into electrical impulses occurs in the outer retina and is accomplished largely by rod and cone photoreceptors and retinal pigment ...

MRI Mapping of Cerebrovascular Reactivity via Gas Inhalation Challenges

脑血管反应性通过气体吸入挑战MRI映射

The brain is a spatially heterogeneous and temporally dynamic organ, with different regions requiring different amount of blood supply at different time. ...

Dry Powder and Nebulized Aerosol Inhalation of Pharmaceuticals Delivered to Mice Using a Nose-only Exposure System

干粉和药品的雾化吸入气雾剂递送小鼠使用鼻只曝光系统

Obstructive respiratory diseases like asthma and chronic obstructive pulmonary disease (COPD) are currently treated by inhaled anti-inflammatory and ...

Comparing the Effects of Electronic Cigarette Vapor and Cigarette Smoke in a Novel In Vivo Exposure System

Comparing the Effects of Electronic Cigarette Vapor and Cigarette Smoke in a Novel In Vivo Exposure System

比较电子烟和烟雾在小说中的影响<em&gt;体内</em&gt;曝光系统

Electronic cigarettes (E-cigarettes) are being widely used, and growing in popularity. It is estimated that more than 9 million adults use them regularly. ...