Yin Yu-Xia, Gao Wei, Li Xu-Ying, Lu Wei, Deng Qian-Hong, Zhao Cui-Yun, Liu Xue-Rong, Zhou Chao, Hou Wen-Bo, Lu Shou-Tao, Liu Guang, Wang Lu-Ning, Li Mao-Quan, Zhang Hai-Jun
1 School of Materials Science and Engineering, University of Science & Technology Beijing, Beijing, China.
2 National United Engineering Laboratory for Biomedical Material Modification, Dezhou, China.
J Vasc Access. 2019 Sep;20(5):524-529. doi: 10.1177/1129729818819732. Epub 2018 Dec 31.
Ultrasound-guided venipuncture and tip location by intracavitary electrocardiogram have many advantages during the insertion of peripherally inserted central catheters, both in terms of safety and cost-effectiveness. Recently, a new tip-conductive peripherally inserted central catheters and new Doppler ultrasound device integrated with intracavitary electrocardiogram have been introduced into clinical practice in China. A randomized multicenter study (clinical trial no. NCT03230357) was performed to verify the feasibility and accuracy of intracavitary electrocardiogram, as performed with this new peripherally inserted central catheters and device.
Our study enrolled a total of 2250 adult patients in 10 different Chinese hospitals. The patients were randomly assigned to either the study group (intracavitary electrocardiogram) or the control group (anatomical landmark guidance) in a 2:1 allocation. Ultrasound was used in both groups for venipuncture and tip navigation. All patients underwent chest X-ray after the procedure to verify the position of the catheter tip.
No insertion-related complications were reported in either group. In the study group, first-attempt successful tip location was 91.7% (95% confidence interval: 90.3%-93.1%), significantly higher than 78.9% (95% confidence interval: 76.0%-81.9%) observed in the control group (p < 0.001). As evaluated by post-procedural chest X-ray, tip location in the study group had a sensitivity of 99.3% (95% confidence interval: 98.8%-99.7%), significantly higher than 86.8% (95% confidence interval: 84.4%-89.2%) observed in the anatomical landmark group (p < 0.001).
These results indicated that during peripherally inserted central catheters insertion in adult patients, tip location with intracavitary electrocardiogram guidance, as carried out by a new tip-conductive peripherally inserted central catheters and intracavitary electrocardiogram integrated ultrasound device, was more effective and more accurate than tip location using anatomical landmarks.
在置入外周静脉中心导管过程中，超声引导下静脉穿刺及通过腔内心电图进行尖端定位在安全性和成本效益方面均具有诸多优势。最近，一种新型的尖端导电外周静脉中心导管以及集成了腔内心电图的新型多普勒超声设备已在中国临床实践中得到应用。开展了一项随机多中心研究（临床试验编号：NCT03230357），以验证使用这种新型外周静脉中心导管和设备进行腔内心电图检查的可行性和准确性。
我们的研究共纳入了中国10家不同医院的2250例成年患者。患者按2:1的比例随机分配至研究组（腔内心电图组）或对照组（解剖标志引导组）。两组均使用超声进行静脉穿刺和尖端导航。所有患者在操作后均接受胸部X线检查以确认导管尖端的位置。
两组均未报告与置入相关的并发症。在研究组中，首次尝试时尖端定位成功的比例为91.7%（95%置信区间：90.3%-93.1%），显著高于对照组观察到的78.9%（95%置信区间：76.0%-81.9%）（p<0.001）。根据操作后的胸部X线评估，研究组中尖端定位的敏感性为99.3%（95%置信区间：98.8%-99.7%），显著高于解剖标志组观察到的86.8%（95%置信区间：84.4%-89.2%）（p<0.001）。
这些结果表明，在成年患者置入外周静脉中心导管过程中，使用新型尖端导电外周静脉中心导管和集成了腔内心电图的超声设备进行腔内心电图引导下的尖端定位，比使用解剖标志进行尖端定位更有效、更准确。
