中心静脉导管临床使用调研与风险分析

Investigation and risk analysis on clinical use of central venous catheters

目的:调研医疗机构使用中心静脉导管(CVC)引流积液情况,为临床CVC使用监管提供数据支持与风险控制策略。方法:采用问卷星在线调查平台线上无记名问卷调查方式,针对医疗机构使用CVC引流胸、腹腔积液相关情况展开调查,分析其相关风险因素,提出风险控制建议。结果:调研共收到有效问卷13 150份,涉及全国28个省份262个市、区(县)的各级医疗机构。13 150份有效问卷中6 503份(占49.45%)认为CVC可用于胸、腹腔等部位积液引流,10 411份(占79.17%)认为CVC用于引流的主要原因是临床操作方便和可一次性完成,7 449份(占56.65%)认为较其他产品成本低等。临床使用CVC引流存在因胸腔、腹腔压力变化或积液性质导致导管弯折、堵塞及脱落等不良事件,积液分布特点、导管尺寸不合适等可能增加引流不完全或引流失败。结论:CVC用于胸、腹腔积液引流属于超适应范围使用,医疗器械生产企业、医疗机构及监管机构应加强对CVC用于胸腔腔、腹腔等部位积液引流全过程的风险控制,提高临床医务人员风险认知程度。

Objective:To investigate the use of central venous catheter(CVC)for effusion drainage in medical institutions in China,and to provide data support and risk control suggestions for clinical supervision of CVC use.Methods:An anonymous questionnaire survey was conducted on Wenjuanxing online survey platform to investigate the use of CVC to drain pleural and abdominal effusions in medical institutions in China.The relevant risk factors were analyzed and the risk control suggestions were proposed.Results:A total of 13,150 valid questionnaires were collected for the study,involving medical institutions at all levels in 262 cities and districts(counties)in 28 provinces across China.Among 13,150 valid questionnaires,6,503(accounting for 49.45%)considered that CVC could be used for drainage of effusion of pleural,abdominal cavity and other parts;10,411(accounting for 79.17%)believed that the main reason for CVC to be used for drainage was that it was convenient for clinical operation and could be completed at one time;7,449(accounting for 56.65%)considered that the cost was lower than other products.The clinical use of CVC drainage had adverse events such as bending,obstruction and falling-off of the catheter due to the change of pressure in pleural and abdominal cavity or the nature of fluid accumulation.The distribution characteristics of effusion and inappropriate catheter size may increase incomplete drainage or drainage failure.Conclusion:The use of CVC for drainage of pleural and abdominal effusion is using beyond the scope of application.Medical equipment manufacturers,medical institutions and regulators should strengthen risk control of the whole process of CVC for drainage of effusion of pleural,abdominal cavity and other parts,and enhance the risk awareness of clinical medical staff.