HFT Nasal Cannula 临床研究(7)

Vapotherm的安全性和有效性的评估是由针对25–29周胎龄的新生儿设计的早期拔管协议比较历史对照结果而得出的。21当使用呼吸机的天数相同，较多新生儿使用Vapotherm14天或不到14天即可拔去套管，更多的因通气率大于等于30次/分钟拔去套管。

Although no details are provided of how patients had previously been managed, the authors concluded that Vapotherm appeared safe and well tolerated, that more patients in the Vapotherm group spent less than 2 weeks on the ventilator and additional benefits may include decreased rate of pneumonia and improved growth.

虽然没有详细资料说明患者在此之前是如何做到的，但我们总结为Vapotherm具有安全性和良好的耐受性。更多使用Vapotherm的患者不到2周时间就不需靠呼吸机来维持，由此产生的附加好处可能包括减少肺炎率和促进成长。

A full peer-reviewed published study examined WOB in 18 stable preterm neonates on CPAP (Inca prongs/Bird ventilator) or Vapotherm for mild RDS, chronic lung disease, or apnea of prematurity.Patients were studied on both devices in random order using CPAP at 6 cm H2O and Vapotherm at flow rates of 3, 4, and 5 L/min. No differences were found in WOB for all settings.

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In addition, changes in end-distending pressure from baseline did not vary significantly over all device settings except Vapotherm at 5 L/min. A nonstatistically significant trend was observed toward increased asynchrony with Vapotherm use. While it is possible that a larger sample size might have found more significant differences, the conclusion was that HHFNC using Vapotherm provides support comparable to 6 cm H2O nasal CPAP for neonates with mild respiratory requirements. The authors did advise caution in clinical use until larger randomized controlled trials at higher flow rates with long-term outcomes are available.

一个完整的同行评议实验针对18名状况稳定早产儿使用CPAP（Inca 鼻塞/Bird 呼吸机)或Vapotherm检测轻微呼吸窘迫综合症、慢性肺疾病或因早产导致的呼吸暂停等呼吸功。22实验中患者将随机使用6 cm 氧气的CPAP和流速率分别为3 L/min, 4 L/min, 和 5 L/min 的Vapotherm。在这些不同的设置中呼吸功并没有产生差异。此外，除了Vapotherm在流速为5 L/min时，其他设置都没有较大的改变基线的膨胀末期压力。没有观测到明确的数字统计趋势表明协调障碍增加。 有可能较大的样本量会产生更显著的差异性。得出的结论是针对有轻微供氧需求的新生儿，与6 cm氧气鼻腔CPAP相比，提供使用Vapotherm用于HHFNC。我们建议除非大量的在高流量率下长期实验得到肯定结果，否则应用于临床应谨慎。

A recent retrospective observational peer-reviewed published study compared frequency of use as well as efficacy and safety of HHFNC following its widespread acceptance into practice in 2 large referral centers with previous outcomes on variable-flow or ventilator-driven CPAP at 3–8 cm H2O. To meet study criteria, neonates had to be placed on one of the support modalities (CPAP or HHFNC) either initially following admission, as an escalation of support from oxyhood or low-flow nasal cannula (≤2 L/min), or immediately following extubation from mechanical ventilation within 96 hours of birth. For neonates with less than 30 weeks’ gestational age, there were no differences in death or bronchopulmonary dysplasia between the groups, but ventilator days per patient were decreased following introduction of HHFNC. In those patients receiving either CPAP or HHFNC as an early mode of respiratory support, more were intubated for failing early CPAP than early HHFNC. A far higher percentage of all neonates was placed on HHFNC in the latter era than those placed on CPAP in the earlier era, and the authors note that some patients may have been placed on HHFNC who otherwise would have done just as well on less respiratory support such as low-flow nasal cannula or room air.

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If true, this might significantly affect outcomes such as intubation and reintubation rates.

近期可追溯的同行评议研究较频繁被使用，同时HHFNC的安全性和有效性随着其在2个大的转诊中心使用3–8 cm氧气变速流或通气设备CPAP的结果被广泛接受并应用于实践。23为达到实验标准，新生儿必须用到一种支持设备(CPAP或 HHFNC)或者初期进气，像是利用加强支持的氧气罩或低流量鼻套管(≤2 L/min),或者出生后96小时使用机械通气然后拔除套管。小于30周胎龄的新生儿组同死亡或支气管肺发育不良没什么区别。但是遵循使用说明的使用呼吸机的患者减少了，见如下HHFNC介绍。这些患者使用CPAP 或者 HHFNC作为早期的呼吸支持工具，与早期HHFNC相比，早期CPAP插管失败率更高。大多数新生儿使用后期HHFNC，少数使用早期CPAP。我们发现一些患者不使用HHFNC的话会减少呼吸支持，比如说低流速鼻套管或室内空气。如此结论成立，这可能是诸如插管法和重插管率之类的重大影响发现。

Another peer-reviewed full study compared 2 methods of delivering high-flow gas therapy by nasal cannula following endotracheal extubation in a prospective, randomized, masked, crossover trial.Thirty moderately preterm neonates averaging 31–32 weeks’ gestation were extubated to Vapotherm for 24 hours, then standard high-flow nasal cannula for 24 hours, or to standard high-flow nasal cannula for 24 hours, then

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Vapotherm for 24 hours. Standard high-flow nasal cannula was not described in detail other than as being provided by a “standard high-flow system,” presumably without effective humidification. Uniform nasal cannulae manufactured by Vapotherm were used for both Vapotherm and standard high-flow nasal cannula support. The nasal gas flow used on Vapotherm was 3.1 ± 0.6 L/min compared with 1.8 ± 0.4 L/min on standard HFNC based on what was considered to be optimal individual support to each patient as judged by the neonatal care team. Vapotherm performed better than standard high-flow nasal cannula in maintaining normal appearing nasal mucosa, a lower respiratory effort, and averting reintubation, with no recognized complications. The better respiratory effort scores were felt to be due at least in part to the higher gas flow used on Vapotherm, with the improved nasal mucosa on Vapotherm the result of the high …… 此处隐藏：3606字，全部文档内容请下载后查看。喜欢就下载吧 ……