气管插管不良事件的研究

      Study of Adverse Events of Endotracheal Intubation

      • 摘要: 目的 为进一步降低和减少硅橡胶材质气管插管在临床使用阶段,尤其是麻醉和重症监护阶段严重不良事件的发生。方法 分析国内发生的四例气管插管严重不良事件个案,综述气管插管类产品浙江省近五年产品不良事件、产品不良事件国内外文献、产品引用标准检索、产品使用说明书内容完整性、严重不良事件专家研讨会,结合近两年气管插管类产品气囊漏气、产品使用材质和临床使用规范性方面给出监管建议和方案。结果 硅橡胶材质气管插管产品在临床重症监护使用中存在一定的临床安全隐患风险,尤其对长时间应用的重症患者。结论 针对在临床重症监护中发生的四例硅橡胶材质气管插管严重不良事件,对生产企业、临床使用单位和监管机构方面提出建议,进一步降低和减少硅橡胶材质气管插管的严重不良事件。

         

        Abstract: Objective In order to further decrease and reduce the serious adverse events of silicone rubber endotracheal intubation in clinical use, especially in anesthesia and intensive care. Methods Through the first stage analysis on the registration and certification of endotracheal intubation products in China, adverse events of products in recent five years in Zhejiang province, domestic and foreign literature of adverse events of products, retrieval of product citation standards, content integrity of product instructions, and expert seminar on serious adverse events, combined with the air leakage of endotracheal intubation products in recent two years, product material and clinical application with normative aspects. Results Silicone rubber endotracheal intubation products in clinical intensive care have certain clinical safety risks, especially for long-term use of critically ill patients. Conclusion According to the four cases of serious adverse events of silicone rubber endotracheal intubation in the clinical intensive care unit, we put forward some suggestions for the manufacturers, clinical users and regulatory agencies to further decrease and reduce the serious adverse events of silicone rubber endotracheal intubation.

         

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