HFT Nasal Cannula 临床研究(9)

迄今为止，仅出版的少数刊物中没有注明发病感染率的增加。一项实验室研究包括细菌过滤组件的Vapotherm组件有效性测试。27然而，美国疾病控制与预防中心2005年后期启动了一项关于由使用Vapotherm出现的罗尔斯顿菌属的调查研究。罗尔斯顿菌属为环境中发现的革兰氏阴性菌，主要在水里和植物上，偶尔从临床研究样本分离取得。这些生物体之前存在假单胞菌属或伯克氏菌属，但DNA特性使它们成显形菌属。感染罗尔斯顿菌属的症状与其他细菌感染相似。来自16个州的32个研究机构报道了大约40名儿科使用Vapotherm设备后罗尔斯顿菌属感染恢复。大多数这样的案例似乎是在稳定Vapotherm的地位，即便已有8例潜在感染的报告和1例死亡报告。从不使用Vapotherm组件的2个医院也出现了罗尔斯顿菌属感染。制造商推荐的改良的消毒协议并没有起到持续作用，同时个别报道指出Vapotherm污染包括一些罕见细菌，例如洋葱伯克霍尔德菌、肺炎杆菌、变形杆菌属等。2005年10月13日， FDA建议不再使用Vapotherm并自愿召回Vapotherm。随后2006年1月24日在全国范围内开展召2007年1月4日，FDA批准该产品附全新使用说明重新上市。回行动。

使用说明包括建议仅在无菌水中使用该系统。5这次经历至少说明中心在使用重新上市的Vapotherm设备（或其他类似设备）时，在大规模的随机控制实验没有对此潜在问题做出满意的处理方式之前都应密切监控它们的感染率和任何不寻常的感染。

Concerns regarding excessive airway pressure generation with

HHFNC have been addressed earlier in this review. 我们关注的关于HHFNC产生过度呼吸道压力问题，上文中已提及处理方法。

There have been isolated anecdotal reports on Internet news groups of facial chemical burns from improperly cleaned and recycled nasal cannulae, and of a perforated eardrum associated with the use of Vapotherm. It would be inappropriate to assign a cause-effect relationship to such unsubstantiated anecdotal reports that are noted not to suggest that such a relationship necessarily exists, but rather to highlight the need for large randomized controlled trials to adequately address any concerns and to identify any true, currently unidentified, potential adverse effects.

个别来自网站上的面部化学烧伤新闻组的轶事报道称使用的Vapotherm未经正确净化消毒、鼻套管是回收利用的、引起鼓膜破损等。这些无事实根据的轶事报道所列出的必然存在的因果关系是不恰当的，应该强调需要大规模的随机控制实验来充分说明我们所关心的并鉴定出什么是真的、当前所不明确的、潜在的副作用

It is interesting to note the abstract-only study of nursing satisfaction with what were termed 4 nasal distending pressure

devices in the NICU, including Vapotherm (demonstrating again the ambiguous perception of the intended use of Vapotherm).

28

This survey of 17 NICU bedside nurses involved 11 questions regarding nursing satisfaction with Neotech Binasal Airway/ventilator CPAP, Hudson prongs/bubble CPAP, ARABELLA prongs/flow-driver

CPAP,

and

Vapotherm

nasal

cannula/high-flow gas. The Vapotherm device scored consistently highest, with the Neotech Binasal Airway scoring second highest in most categories. No differences were reported between the Hudson prongs and Arabella setup devices, which were the least favored overall. The authors concluded that if safety and efficacy of the 4 devices were equal, then nursing satisfaction could be considered an important factor in choosing a device. It should be noted that a separate study showed that a device very similar in design to the Neotech device had the highest resistance of a wide range of such devices tested, in all likelihood making it the least desirable clinically in terms of effectively transmitting any generated CPAP to the patient airway. This highlights one potential concern with choosing the most convenient or user-friendly device, unless quality efficacy and safety data are also available to support such a choice.

29

有趣的是，护理满意度的仅抽象研究术语中新生儿重症监护室使用的4种鼻腔压力设备就包含Vapotherm（这再次证明了Vapotherm使用目的模糊不清的概念）。2817个新生儿重症监护室床边护士对使用Neotech鼻侧呼吸机CPAP、Hudson鼻塞/气泡CPAP、ARABELLA鼻塞/气流驱动CPAP和Vapotherm鼻套管/高流速气体的护理满意度有11个疑问。Vapotherm得分始终是最高的，其次是Neotech鼻侧呼吸机。没有报告指出最不受欢迎的Hudson 和 Arabella这2个设备的不同之处.我们总结为当这4种设备的安全性和有效性一样的时候，护理值得注意的是一项独立研究显满意度成为选择一种设备的最要因素。

示与Neotech设备设计类似的产品中，Neotech设备与大范围的已测试类似设备相比，其耐受性最高。这很可能使其成为临床上向患者有

29效传输产生任何CPAP最不想用的设备。潜在关注强调选择一种最方

便最容易使用的设备还要考虑到该产品的质量有效性和安全性。

WHY MIGHT HHFNC BE PREFERRED TO (AND POSSIBLY BETTER THAN) CPAP?

为什么HHFNC优于CPAP（可能比CPAP更好）？

Given that CPAP, in design at least, should provide consistent, predictable, and regulated positive air-way pressure, as well as has been extensively researched in the neonatal population, it is important to consider why the use of HHFNC has become so widespread and popular as a respiratory support modality, in

many cases in preference to CPAP, despite not meeting these same criteria. One possibility is that an easy-to-use suboptimal system for delivering positive airway pressure is better and more effective than a hard-to-use but, in theory, more optimally designed system. This presumes both that caregivers are using the HHFNC as a CPAP device and that the HHFNC is achieving its benefits by providing airway pressure. Although some airway pressure generation is highly likely with HHFNC, it is unclear at this stage whether this is therapeutic, trivial, or excessive, or some combination of the 3 at different times. It has been suggested that HHFNC may produce desirable respiratory benefits in some other manner related to flow, improved mucosal perfusion, or respiratory stimulation, although this remains purely speculative at this stage. If true, it is entirely possible that HHFNC may be more effective in certain patients and/or disease processes than conventio …… 此处隐藏：3344字，全部文档内容请下载后查看。喜欢就下载吧 ……