多普勒超声腔内心电一体化引导肿瘤患者床旁中心静脉置管的安全性与准确性的随机对照研究

Safety and Accuracy of Doppler Echocardiography-Guided Bedside Central Venous Catheterization in Cancer Patients:A Randomized Controlled Study

目的:研究多普勒超声腔内心电一体化引导(electrocardiography and Doppler ultrasound guidance, EDUG)引导肿瘤患者床旁中心静脉置管的安全性与准确性。方法:2021年3月至12月共320例床旁中心静脉置管的肿瘤患者参与研究,根据随机数字生成器软件生成随机数,将研究对象随机分为对照组和试验组,最终失访35例,285例纳入研究。试验组151例采取EDUG引导中心静脉置管,对照组134例采取普通超声仪引导中心静脉置管,通过一次性穿刺成功率、一次性送管成功率、导管尖端标准到位率、导管尖端精准到位率、并发症发生率等指标比较两种穿刺引导方式的安全性,通过置管耗时、输液等待时间比较两种穿刺引导方式的时间效率,使用Mc Nemar检验与Kappa一致性检验分析心腔内心电图(intracavitary electrocardiography, IC-ECG)和胸部X线(chest X-ray, CXR)诊断导管尖端精准到位的一致性与准确性,计算IC-ECG诊断中心静脉导管精准到位的灵敏度、特异度、约登指数、准确度、假阳性率、假阴性率、阳性预测值和阴性预测值。结果:试验组导管尖端标准到位率与精准到位率均高于对照组(χ^(2)=6.053,P=0.014;χ^(2)=15.952,P <0.001);试验组输液等待时间低于对照组(χ^(2)=43.472,P <0.001),两组一次性穿刺成功率、一次性送管成功率、置管耗时及带管期间并发症发生率的差异无统计学意义(P> 0.05)。IC-ECG技术与CXR诊断中心静脉导管尖端精准到位两种方法的Mc Nemar检验结果P为0.500,Kappa一致性检验Kappa值为0.661(P <0.001)。IC-ECG诊断中心静脉导管精准到位的灵敏度为98.66%、特异度为100%、约登指数为0.99、准确度为98.68%、假阳性率为0、假阴性率为1.34%、阳性预测值为100%、阴性预测值为50%。结论:EDUG引导床旁肿瘤患者中心静脉导管置管较传统超声引导置管具有较好的安全性,IC-ECG与CXR诊断导管尖端到位具有较好的准确性,且EDUG引导穿刺和精准定位导管尖端能够明显缩短输液等待时间,适合应用于肿瘤患者的床旁CVC置管。

Objective :To study the safety and accuracy of bedside central vein catheterization guided by electrocardiography and Doppler ultrasound in cancer patients. Methods : A total of 320tumor patients with bedside central venous catheterization from March 2021 to December 2021 participated in this study. According to random numbers generated by a random number generator, the subjects were randomized into control group and test group. Finally, 35patients were lost to follow-up, and 285 were included in the study. 151 patients in the test group were guided by Doppler ultrasound and electrocardiography for central venous catheterization. In the control group, 134 cases were catheterized under the guidance of ordinary ultrasound instrument. Safety of the two catheterization guidance methods was compared in terms of success rate of one-time puncture, success rate of one-time catheterization, catheter tip standard placement rate, catheter tip optimal placement rate, incidence of complications and other indicators. Time efficiency of the two catheterization guidance methods was compared by evaluating catheterization time and infusion preparation time. McNemar test and Kappa consistency test were used to analyze the consistency and accuracy of intracardiac electrocardiogram(IC-ECG) and chest X-ray(CXR) in the diagnosis of catheter tip optimal placement. The sensitivity, specificity, Youden index, accuracy, false positive rate, false negative rate, positive predictive value and negative predictive value of IC-ECG in the diagnosis of central venous catheter(CVC) optimal placement were calculated. Results : Catheter tip standard placement rate and catheter tip optimal placement rate in the test group were higher than those in the control group (χ^(2) = 6.053, P = 0.014;χ^(2) = 15.952, P < 0.001).Infusion preparation time in the test group was lower than that in the control group (χ^(2) = 43.472, P < 0.001). There were no statistically significant differences between the two groups in success rate of one-time puncture, success rate of one-time catheterization, catheterization time and the incidence of complications(P > 0.05). The results of McNemar test and Kappa consistency test for IC-ECG and CXR in the diagnosis of CVC optimal placement were P = 0.500 and Kappa = 0.661(P < 0.001). The sensitivity, specificity, Youden index, accuracy, false positive rate, false negative rate, positive predictive value and negative predictive value of IC-ECG in the diagnosis of CVC optimal placement were 98.66%, 100%, 0.99, 98.68%, 0, 1.34%, 100% and 50%, respectively. Conclusion : Compared to traditional ultrasound-guided central venous catheterization, electrocardiography and Doppler ultrasound guided central venous catheterization has better safety for cancer patients. IC-ECG and CXR are accurate in diagnosing CVC tip placement. Electrocardiography and Doppler ultrasound guided puncture and catheter tip positioning can significantly shorten infusion preparation time, which is especially suitable for beside central venous catheterization in cancer patients.