气道打开体位自动调节装置的有效性与安全性实证研究

陈红梅; 孙敏越; 罗艳; 杨相梅

doi:10.13406/j.cnki.cyxb.003758

重庆医科大学学报 ›› 2025, Vol. 50 ›› Issue (04) : 530 -535. DOI: 10.13406/j.cnki.cyxb.003758

临床研究

气道打开体位自动调节装置的有效性与安全性实证研究

陈红梅 ¹ ,
孙敏越 ² ,
罗艳 ² ,
杨相梅 ²

作者信息 +

Efficacy and safety of the airway opening device with automatic position adjustment: an empirical study

Author information +

文章历史 +

PDF (1108K)

摘要

目的评价一种新型气道打开仪器临床应用的效果。方法通过方便抽样于2021年1月4日至3月15日选取360例行电子支气管镜检查或治疗的患者为研究对象，由研究助理按照计算机生成的随机序列先后调整仪器的体位夹角为90°（仪器90°组）、95°（仪器95°组）或100°（仪器100°组）打开受试者气道，支气管镜进入受试者气道并观察到受试者最清晰的声门视野时，系统采集并保存此时的声门视野电子图像；研究结束后于立即、0.5、1、3、6、12、24 h随访观察患者有无与仪器相关的不良反应。主要评价指标为声门视野暴露分级（cormack-lehane，CL）分级，次要评价指标为不良反应发生率和视觉模拟疼痛评分（visual analogue scale，VAS）。结果 >80.0%受试者的CL分级为I级，3组角度之间的CL分级差异无统计学意义（χ²=1.942，P>0.05），但仪器角度为100°时，部分受试者的CL分级得到了优化；仪器不良反应发生率为0及VAS评分均为0分。结论该装置在体位夹角90°~100°下均能安全且有效地打开支气管镜诊治患者的气道，其在改善声门视野暴露方面虽没有体现出与角度大小相关的明显优势，但建议使用优先考虑选择100°。

Abstract

Objective To investigate the efficacy and safety of a new airway opening device with automatic position adjustment. Methods From January 4 to March 15，2021，the purposive sampling method was used to select 360 patients who underwent bronchoscopy examination or treatment. According to the random sequence generated by a computer，the research assistant adjusted the position angle（PA） as 90°（90° PA group），95°（95° PA group），and 100°（100° PA group），respectively，to open the airway of subjects，and the bronchoscope entered the airway to obtain the image of the best glottic view. All subjects were followed up immediately after study and at 0.5，1，3，6，12，and 24 hours after study to observe device-related adverse events. The primary outcome measure was the Cormack-Lehane（CL） grade for glottic exposure，and the secondary outcome measures were the incidence rate of adverse events and Visual Analogue Scale（VAS） score. Results More than 80.0% of the subjects had CL grade I glottic exposure，and there was no significant difference in CL grade between the three PA groups（χ² =1.942，P>0.05）. The CL grade of some subjects was optimized at an angle of 100°. No device-related adverse events were reported，and the VAS score was 0. Conclusion The device can effectively and safely open the airway of subjects undergoing bronchoscopy at a PA of 90°-100°，and although it has no obvious advantage in improving glottic exposure at different levels of PA，it is recommended to select the PA of 100° to open the airway.