HFT Nasal Cannula 临床研究(8)

31-32周的中等早产儿在使用Vapotherm24小时后拔管，然后经鼻套管提供24小时的标准高流速气体，或者经经鼻套管提供24小时的标准高流速气体后再使用Vapotherm24小时。标准高流量鼻套管并非像提供“标准高流量体系”那样假定无有效增湿的情况下详细描述细节。Vapotherm公司制造的统一鼻套管既可用于Vapotherm治疗又可用于高流速鼻套管支持。Vapotherm使用的鼻腔气流为3.1 ± 0.6 L/min，相比之下，由新生儿护理团队判断作为个人可选择性呼吸支持的标准HFNC鼻腔气流为1.8 ± 0.4 L/min。在维持正常出现的鼻腔粘液方面、下呼吸道支运作方面、避免重插管方面，Vapotherm比标准的高流速鼻套管效果要好，没有出现其他并发症。更好的呼吸运作记录至少在某种程度上由于使用已改善的鼻粘膜在更高气流的Vapotherm下，产生更加增湿增温的气体。正如胸内压力无法测量一样，我们不清楚在不同分组中更高Vapotherm流速率下，改善的呼吸运作记录是否与其他潜在气压产生有关。

In 40 preterm neonates weighing 1250 g or less who were extubated to what was termed high-flow CPAP (HF-CPAP) of 4.5 cm H2O (calculated using the previously mentioned formula, and using a non-heated bubble humidifier and nasal cannula) or to infant flow CPAP (IF-CPAP) of 6 cm H2O,HF-CPAP failed to maintain extubation status as effectively as IF-CPAP. Patients in the HF-CPAP group also had higher oxygen use and increased

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number of apnea/bradycardia episodes postextubation. Importantly, this study used nonheated, ineffectively humidified gas, and delivered a calculated CPAP in the HF-CPAP group that was lower than that in the IF-CPAP group, as well as being lower than the 5 cm H2O limit that was noted in prior studies to be potentially important in the prevention of reintubation.

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在40名重小于等于1250G的新生儿中，拔管后使用所谓的4.5cm氧气高流速CPAP(HF-CPAP)（由之前提到的公式计算得出，同时使用无加温增湿器和鼻套管），或使用婴儿气流6 cm氧气的 CPAP (IF-CPAP)。

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HF-CPAP同IF-CPAP效果一样，都无法维持拔管后的状态。HF-CPAP

组的患者拔管后出现了更高的氧气需求和数目不断上升的呼吸暂停/心动过缓。重要的是，这次实验使用的是无加温无加湿的气体，并且HF-CPAP组中计算出的CPAP低于IF-CPAP组，同时也低于之前我们提到的预防重插管重要的潜在因素的5cm氧气限制。26 HHFNC: INDICATIONS FOR USE: CONCLUSIONS HHFNC:使用说明：结论

Collectively, these studies suggest a wide potential role for HHFNC in respiratory care of the neonate, and in some cases, the available data are encouraging. However, the highly variable study populations, clinical circumstances, and

abstract-only nature of much of the limited published literature highlight the difficulty in assessing what, if any, role HHFNC should play in respiratory support of the neonate, as well as the efficacy and safety of HHFNC in such role. 所有这些实验都说明HHFNC对新生儿呼吸支持的广泛潜在角色，在某些案例中，一些有效的数据是鼓舞人心的。然而，变化较大的研究对象、临床环境、和许多有限出版的仅抽象特性使得文献强调很难去审评它的本质。如果可以的话，HHFNC的角色应该定义为为新生儿提供有效的、安全的呼吸支持。

IS HHFNC SAFE? 使用HHFNC 安全吗？

Many of the previously quoted studies have commented on the safety of HHFNC (in most cases Vapotherm) in their study populations. Unfortunately, the majority of these studies suffer from one or more of being observational studies, having low study population numbers, heterogeneous study populations, different primary respiratory illnesses, or being available in abstract-only form with limited details. Concerns that have been or might reasonably be expressed include incidence of infection, excessive airway pressure generation, local trauma,

and other as yet unidentified adverse effects.

很多之前引用的研究实验通过其研究对象对HHFNC的安全性做出了评价。不幸的是，这些实验大多数是通过一个或多个观测性研究，研究对象少、研究对象群类似、初期呼吸疾病类似，或从仅抽象形式中获得有限的信息。值得关注的是它可能出现的副作用包括发病感染率、产生过多的气压、局部创伤、和一些尚不明确的不良反应

None of the few publications to date have noted an increased incidence of infection, and a laboratory study testing effectiveness of the Vapotherm cartridge concluded that the cartridge may be expected to act as an effective bacteriological filter.However, the Centers for Disease Control and Prevention launched an investigation in late 2005 regarding Ralstonia spp associated with the use of Vapotherm.

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Ralstonia are gram-negative bacteria found in the environment,

primarily in water, soil, and on plants, and occasionally are isolated from clinical samples. These organisms were formerly included in the genus Pseudomonas or Burkholderia, but DNA characterization has revealed them to be a distinct genus. Signs and symptoms of an infection with Ralstonia are similar to those observed in other bacterial infections. Up to 32 institutions in 16 states reported recovery of Ralstonia from

Vapotherm devices and from approximately 40 pediatric patients. The majority of these cases appeared to represent colonization, although there were 8 reported potential infections and 1 reported death. Cultures of unused Vapotherm cartridges performed by 2 hospitals also yielded Ralstonia. A revised disinfecting protocol recommended by the manufacturer was not found to be consistently effective, and there were isolated reports of contamination of Vapotherm units with other uncommon bacteria

including

Burkholderia cepacia, Klebsiella pneumoniae, and Proteus mirabilis. This led to an FDA

recommendation against use and a voluntary recall of Vapotherm on October 13, 2005, followed by a nationwide recall on January 24, 2006. The product returned to the market with FDA approval on January 4, 2007, with new instructions for use, including the recommendation to utilize only sterile water in the system.

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This experience suggests that, at the very least,

centers using the reintroduced Vapotherm device (or other similar de …… 此处隐藏：3290字，全部文档内容请下载后查看。喜欢就下载吧 ……