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HFT Nasal Cannula 临床研究(2)

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Difficulties with successful application of CPAP are principally related to the relatively bulky interface with the patient leading to problems maintaining proper position and effectiveness (Figure 1). Unless well-designed equipment is appropriately selected, carefully applied, and maintained, leaks around the nares and via the mouth can result in inconsistent air-way pressure generation, increased WOB, and respiratory instability with increased oxygen requirements. Similarly, poor system design, prong selection, or application, along with the inherently bulky nature of most CPAP interfaces, can predispose to nasal irritation and trauma.

成功应用CAPA 的困难主要与患者和CAPA设备之间相对大的接口导致不能维持正确的位置和效果有关(图1.)除非挑选精心设计的设备小心的应用和维持,否则从鼻孔和嘴漏出的气会导致产生不稳定的气压、增加呼吸功、对氧气的需求量增加等导致呼吸不稳定的因素。同样的,不良的系统设计、套管的选择或应用,与大多数CPAP接口一同使用会引起鼻刺激和创伤。 WHAT IS HHFNC? 什么是HHFNC?

Until the recent development of HHFNC devices, the provision of nasal cannula gas at a flow rate of more than 2 L/min in

neonates was not recommended,nor considered practical. In addition, humidification of flow rates of 4 L/min or less was not recommended.Both of these recommendations by the American Association for Respiratory Care (AARC) are based on the limited evidence available, and although neither has changed or been adapted, HHFNC therapy has nonetheless become widely utilized and increasingly popular in the United States. The upper limit for standard or low-flow nasal cannula therapy in infants has been variably defined between 0.5 and 2 L/min.

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Although no single universally accepted definition is available for what constitutes HHFNC therapy in neonates, a widely used and reasonable definition would be optimally warmed and humidified respiratory gases delivered by nasal cannula at flow rates between 2 and 8 L/min.

在最近发展应用HHFNC设备之前,鼻套管中气压流速率在新生儿患者中超过2 L/min是不被建议的,更不会用于实践。此外,湿度流速率小于或等于4 L/min也是不可行的。这些建议是美国呼吸治疗学会通过有限的论证提出的。即使这些建议没有改变也没有完善,HHFNC疗法还是得到了广泛的利用并在美国愈加受到大众青睐。规定的上限或新生儿用低流量鼻套管疗法定义在0.5 L/min和 2L/min之间。虽然针对新生儿的HHFNC 疗法目前没有有效的普遍接受的定义,但广泛使用后得出的合理定义为鼻套管在2 L/min和 8 L/min之间传递最佳增

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温增湿呼吸气。

Despite the aforementioned AARC recommendations, the first Food and Drug Administration (FDA)–approved device approved specifically for the provision of HHFNC in neonates was the Vapotherm 2000i in 2004. In the United States, the formal FDA 510(k) approval specifies the intended use of the Vapotherm device as being “to add moisture to and to warm breathing gases for administration to patients, including neonates/infant, pediatrics and adults.”4

不管上文中提及的有关美国呼吸治疗学会的相关规定,(美)食品及药物管理局于2004年批准Vapotherm 2000i ,即HHFNC在新生儿中运用的条款。在美国,FDA 510(k)正式批准并明确Vapotherm设备定义:“增加患者呼吸气体中的温度和湿度,包括新生儿、儿童及成人。”

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The product uses patented membrane technology to deliver molecular vapor with 95% to 100% relative humidity at body temperature through nasal cannula at flow rates between 5 and 40 L/min. A Vapor Transfer Cartridge allows what the company refers to as “low-flow” use at 1–8 L/min in neonates, although this would be substantially higher than flows traditionally used in this population.

该产品利用膜技术经鼻插管传递同人体温度相对湿度达95%到100%的蒸汽分子,流速率在5 L/min 和40 L/min之间。 蒸汽转换筒可在新生儿中进行“低流速”达1–8 L/min ,尽管在这类患者中这种流速率较传统的流速实质上要高一些。

The expectation is that the heat and humidity should prevent airway water loss, airway cooling, thickened secretions, and nasal irritation, allowing high flow rates without nasal drying or bleeding. The lighter and easier-to-apply interface (when compared with most traditional CPAP interfaces) might lessen nasal septal damage, while allowing practitioners and family members to more easily handle and care for infants (Figures 2–3).5

预期温度和湿度应防止导气管水耗、导气管冷却、分泌物增稠和鼻刺激并在无鼻腔干燥和流鼻血的情况下可承受高流速率。更轻便容易的

接口操作(相对于大多数传统的CPAP接口)有可能减少鼻中隔损伤,同时使操作者和家庭成员能更容易的照料新生儿(图2-3)。5

In the wake of an ongoing Centers for Disease Control and Prevention investigation in 2005 into the role of Vapotherm use as an associated risk factor for recovery of Ralstonia spp. from blood and respiratory tract samples of pediatric patients,

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Vapotherm was recalled from the international market from January 2006 until January 2007. This will be discussed in greater detail later in this review.

紧接着2005年美国疾病控制与预防中心研究表明从儿科患者血液和呼吸道采样中发现使用Vapotherm导致罗尔斯顿菌属感染,6于是2006

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