HFT Nasal Cannula 临床研究(6)

. sufficient to produce clinical effects and/or changes in pulmonary function.

. 足以产生临床效果和/或改变肺功能

Based on these characteristics, HHFNC should not be regarded as a form of CPAP. Rather, it is a distinct respiratory support modality that should be assessed on its own merits in the same way that, for example, CPAP, conventional ventilation, and high-frequency oscillatory ventilation are assessed. It should be noted that neither the Vapotherm nor the F&P HHFNC system is approved for or directly marketed by its manufacturer as a device for providing CPAP, although neither company actively discourages what appears to be considerable ambiguity in this area of clinical use. Well-designed randomized controlled trials are urgently needed to clarify the airway pressure effects of HHFNC, as well as to evaluate their potential benefits and/or adverse consequences.

基于这些特征，HHFNC不应看成是CPAP的一种表现形式。相反，它这种独特的呼吸支持疗法应以相同的方式来评估其自身优势。例如，CPAP被评估为一种通用的、高频震荡的通气设备。值得注意的是Vapotherm和F&P HHFNC系统都没有被制造商作为一种提供CPAP的仪器批准或上市，即便这些公司都没有主动阻止这一领域在临床应用上

出现的较大的歧义。急需设计精确的随机对比控制临床试验来阐明HHFNC气道压影响，同时鉴定他们的潜在有利和/或不利的影响。 HHFNC: INDICATIONS FOR USE HHFNC： 使用说明

As previously noted, the indications for use of HHFNC are somewhat nonspecific. No formal recommendations are available for specific clinical indications published by either Vapotherm or Fisher and Paykel. Both manufacturers’ literature limits the description of their products’ use essentially to that of providing warmed and humidified breathing gases. Many centers appear to be using the therapy in circumstances when they might otherwise have used routine low-flow nasal cannulae, and the limited published literature on the subject suggests that many are utilizing HHFNC as a substitute for, or in place of, CPAP. Following is a brief overview of the most relevant available data documenting roles in which HHFNC has been utilized. Again, unless otherwise noted to have been published as a full study in a peer-reviewed journal, quoted studies are available only in abstract form.

如前文所提及的，HHFNC的使用说明并非特别明确。Vapotherm和 Fisher and Paykel都没有针对特定的临床症状出版的正式的推荐规

范。这两个制造商明文规定他们的产品本质上是用于提供增温增湿的呼吸气体。很多中心出现可能本该使用通用低流速鼻套管的情况下却使用这种疗法。就此项目，有限的出版文献表明多数利用HHFNC作为CPAP的代替品。下面是关于利用HHFNC相关的有效数据文献角色的简明概述。当然，除非另有说明来自同行评议期刊的充分研究，否则所有引证仅源于抽象形式。

One center compared the effects of Vapotherm and nasal CPAP in respiratory distress in 28 preterm neonates of approximately 31–32 weeks’ gestation and found that Vapotherm provide as effective respiratory support as CPAP in the initial treatment of respiratory distress.The authors further concluded that efficacy in reducing potential side effects required similar trials involving long-term ventilatory support.

一个中心对28名妊娠期约为31–32周的患有呼吸困难的早产儿进行Vapotherm和鼻腔CPAP治疗的效果对比。得出的结论是Vapotherm同

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CPAP初治呼吸窘迫时提供同样有效的呼吸支持。我们进一步总结，

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有效减小潜在副作用需通过类似的长期呼吸支持实验。

Another center reported on its experience with 109 preterm neonates with a wide range of birth weights (＜500 g to ＞1500 g) in which Vapotherm was used as primary treatment for mild

to moderate respiratory distress syndrome (RDS) in lieu of CPAP or postextubation in place of CPAP.No evidence of barotrauma, CPAP belly, nosocomial infection, nasal trauma, or nasal mucus plugging was reported, and the study concluded that Vapotherm was a safe and effective adjunct to support neonates with respiratory compromise.

另一中心研究报道109名不同体重（＜500 g to ＞1500 g)的早产儿使用Vapotherm代替CPAP或拔管后代替CPAP 作为温和初治缓解呼吸

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窘迫综合症(RDS)的设备。没有报告表明出现气压伤、CPAP胀气、院

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内感染、鼻腔创伤、鼻粘液栓等现象。该实验推论出Vapotherm能为患呼吸窘迫的新生儿提供安全有效的治疗。

In a prospective, observational study of an even more heterogeneous group of 52 preterm and 12 term newborns with respiratory distress (n =27) or following extubation (n =37), Vapotherm was used at decreasing flows as lung disease improved.Only 2 patients required reintubation, and no nasal bleeding, necrotizing enterocolitis, feeding problems, abdominal distention, or failed hearing screens were noted. The study concluded that HHFNC could be used safely in these patients, but that additional studies were needed.

在一个前瞻性观测试验中，更多不同体质的患者包括患有呼吸窘迫(n

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=27)或后期拔管(n =37)的52名早产儿和12名足月新生儿，使用Vapotherm逐渐减低流量使患者的肺功能疾病得到改善。19仅有2名患者需要重新换管插管，但这2名患者都没有出现鼻出血、坏死性肠炎、喂食问题、腹胀、听力失效等问题。由此得出的结论是 HHFNC针对此类患者的使用时安全的， 但也需要其他更多研究。

A study examining the use of Vapotherm for preventing reintubation in 43 neonates with single ventricle following cardiac surgery found that the use of Vapotherm did not decrease the rate of reintubation compared with prior practice, although the abstract did not specify what that prior practice was.一项针对43名经心脏手术留单心室的新生儿为防止重插管而使用Vapotherm的检测试验表明Vapotherm的使用较之前的实验并没有降低重插管率，尽管摘要并没有详细说明之前的实验目的。20

The safety and efficacy of Vapotherm was evaluated following an early extubation protocol designed for neonates of 25–29 weeks’ gestational age, comparing outcomes with historical controls.

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