气道打开体位自动调节装置的安全性应用研究  

Application study on safety of airway opening device with automatic position adjustment

作　　者：陈红梅[1] 李冬梅[1] 孙敏越 罗艳[1] 吴俊 杨相梅[1] CHEN Hongmei;LI Dongmei;SUN Minyue;LUO Yan;WU Jun;YANG Xiangmei(Department of Respiratory and Critical Care Medicine,First Affiliated Hospital of Chongqing Medical University,Chongqing 400016,China;Chongqing Electromechanical Design and Research Institute Co.,Ltd.,Chongqing 401147,China)

机构地区：[1]重庆医科大学附属第一医院呼吸与危重症医学科,重庆400016 [2]重庆市机电设计研究院有限公司,重庆401147

出　　处：《重庆医学》2023年第21期3239-3245,共7页Chongqing medicine

基　　金：重庆市社会事业与民生保障科技创新专项(cstc2016shmszx130038)。

摘　　要：目的探讨一种新型气道打开装置应用的安全性效果。方法采用随机分组的类实验研究设计,于2020年12月4-9日通过目的抽样法选取90名成人志愿者为研究对象,随机分为装置90°组、装置95°组和装置100°组,每组30名。使用该装置打开各组研究对象的气道,持续30 min,研究结束后即刻、0.5、1、3、6、12和24 h随访观察有无与装置相关的不良反应。主要评价指标为不良反应的严重程度分级,次要评价指标为视觉模拟量表(VAS)评分和研究开始前10 min、结束后10 min的生命体征。结果50.0%的研究对象出现了1级不良反应,12.2%为2级,1.1%为3级,其中常见不良反应依次为头皮痛(33.3%)、前额皮肤压红(12.2%)和头皮麻木(11.1%),各组不良反应发生率比较差异无统计学意义(P>0.05)。34.4%的研究对象出现了疼痛(轻度22.2%,中度11.1%,重度1.1%),各组VAS评分比较差异无统计学意义(P>0.05)。装置90°组和100°组研究结束后10 min的心率明显低于开始前10 min(P<0.05)。各组不良反应均为短暂的一过性不良反应,皆在30 min内自行好转或消退,余随访窗内无任何不良反应。结论气道打开体位自动调节装置安全、耐受性良好,适用于人体。Objective To investigate the applied safety effect of a new type of airway opening device.Methods The quasi-experimental research design by randomized grouping was adopted.Ninety adult volunteers were recruited as the study subjects by the purposive sampling from Dec.4 to Dec.9,2020 and randomly divveded into the device 90°group,device 95°group and device 100°group,30 cases in each group.The device was used to open the airway of the subjects in each group for lasting 30 min.The follow up was conducted immediately after the end of the study,at 0.5,1,3,6,12 and 24 h for observing whether the device-related adverse reactions occurring.The main evaluation indicators were the severity grading of adverse reactions,and the secondary evaluation indicators were the visual analogue scale score and the vital signs at 10 min before and after the study.Results 50%of the study subjects appeared the grade 1 adverse reactions,12.2%was the gradeⅡand 1.1%was the gradeⅢ,in which the common adverse reactions were in turn the scalp pain(33.3%),pressure redness of forehead skin(12.2%)and scalp numbness(11.1%).The incidence rate of adverse reactions had no statistical difference among the 3 groups(P>0.05).34.4%of the study subjects appeared pain(mild in 22.2%,moderate in 11.1%and severe in 1.1%)and there were no significant differences in the VAS scores among the 3 groups(P>0.05).The heart rate at 10 min after the study end in the device 90°group and device 100°group were significantly lower than that at 10 min before the study beginning(P<0.05).All adverse reactions in each group were temporary,which were improved or subsided within 30 min.There were no adverse reactions during the remaining follow-up window.Conclusion The airway opening de-vice with automatic position adjustment is safe,well-tolerated and suitable for the human body.

关 键 词：气道管理 医疗设备 安全 随机 类实验研究 

分 类 号：R197.39[医药卫生—卫生事业管理]