NV8新生儿呼吸机临床试验

Clinical Trial of NV8 Neonatal Ventilator

目的：探讨NV8新生儿呼吸机四种无创模式的有效性及安全性。方法：选取2014年10月至2015年1月需要无创呼吸支持的新生儿108例,随机分为试验组（NV8呼吸机）和对照组（美国康尔福盛公司Infant Flow Si PAP婴儿呼吸机）,各组根据病情选用不同辅助通气模式6小时。观察各组试验前后血气变化、不良事件发生率。结果：NCPAP组、NIPPV/SNIPPV组、HFNC组中试验组与对照组相比,动脉血氧分压、二氧化碳分压、血PH值变化无统计学差异（P〉0.05）,NCPAP组试验组动脉氧分压非劣效界值下限低于对照组,余组各指标的95%CI下限均大于非劣效界值。各组均未出现不良事件。结论：NV8新生儿呼吸机在新生儿中应用具有有效性和安全性。

Objective：To observe the efficacy and safety of four noninvasive modes by NV8 ventilator in newborns.Methods：The study was carried out from October 2014 to January 2015,108 patients with non-invasive respiratory support were randomized to experimental group（NV8）and control group（Infant Flow Si PAP,USA）,according to the patient＇s condition each group was selected to use different ventilation mode for 6 hours.The changes of blood gas analysis,the incidence of adverse events were observed before and after the experiment.Results：in NCPAP group,NIPPV/SNIPPV group,HFNC group,arterial oxygen partial pressure,carbon dioxide pressure,blood p H changes had no significant difference between experimental group and control group（P〉0.05）,in NCPAP group,The lower limit of non inferiority value of arterial oxygen partial pressure in experimental group was lower than in control group,The lower bounds of the 95%CI in the other groups were larger than the non inferiority margin.No adverse events occurred in all groups.Conclusion：it was effective and safe in neonates by using NV8 ventilator.