具有高效过滤和恒定泄气量功能的无创正压通气面罩研制及功能测试

目的研发一种具有高效过滤和恒定泄气量功能(EFCL)的无创正压通气(NPPV)面罩,并探讨其有效性。方法进行EFCL面罩发明设计,并完成其产品制造。将20例健康人作为研究对象,根据不同面罩类型分为两组:试验组采用EFCL面罩;对照组采用传统NPPV面罩和侧孔型呼气阀的组合。每个研究对象均采用试验组和对照组的前后交叉研究。在标准化试验条件及呼气气道正压(EPAP)为5、10 cm H₂O条件下,监测两组面罩内呼气末二氧化碳分压(Pet CO₂);吸气气道正压(IPAP)从5 cm H₂O逐步递增至10、15、20 cm H₂O时,监测两组各节点呼气阀泄气量;评价两组面罩操作性和舒适性。结果在相同EPAP水平(5 cm H₂O或10cm H₂O),试验组面罩内Pet CO₂均显著低于对照组(均P<0.05);IPAP从5 cm H₂O逐步递增至20 cm H₂O时,试验组呼气阀泄气量维持相对恒定,对照组呼气阀泄气量则随IPAP压力增高而增加。两组面罩的操作性、舒适性均具有较高的满意率和一致性。结论EFCL面罩具有高效过滤和恒定泄气量的功能,为降低NPPV面罩应用中的交叉感染风险提供新方法。

Development and function test of noninvasive positive pressure ventilation mask with efficient filtration and constant leakage

Objective To develop a noninvasive positive pressure ventilation(NPPV)mask with efficient filtration and constant leakage(EFCL)and to explore its effectiveness.Methods The EFCL mask design and the production and manufacturing of mask were completed.Twenty healthy subjects were studied and divided into two groups according to the different mask types:the test group used EFCL masks;the control group used a combination of traditional NPPV masks and side-hole type expiratory valves.Each of the subjects was cross-referenced before and after the test group and the control group.Under standardized experimental conditions and EPAP of 5 and 10 cm H₂O,Pet CO₂ was monitored in the two groups;when IPAP was gradually increased from 5 cm H₂O to 10,15 and 20 cm H₂O,the amount of expiratory valve leakage at each node of the two groups was monitored;the operability and comfort of the masks were evaluated.Results At the same EPAP level(5 cm H₂O or10 cm H₂O),Pet CO₂ in the test group was significantly lower than that in the control group(both P<0.05);when IPAP was gradually increased from 5 cm H₂O to 20 cm H₂O,the expiratory valve leakage remained relatively constant in the test group and increased with increasing IPAP pressure in the control group.The operability and comfort of the two groups had high satisfaction rate and consistency.Conclusion EFCL masks with efficient filtration and constant leakage provide a new approach to reduce the risk of cross-infection in NPPV application.