Department of Vascular & Intervention, Tenth Peoples' Hospital of Tongji University, Shanghai, China.
School of Materials Science and Engineering, University of Science and Technology, Beijing, China.
Phlebology. 2020 Sep;35(8):614-622. doi: 10.1177/0268355520921357. Epub 2020 May 6.
The intracavitary electrocardiogram (IC-ECG) method has been used for the tip location of central venous access devices for the advantage of being safe, accurate and highly cost effective. However, long-term follow-up is rare. This randomized clinical trial aimed to evaluate the long-term complications of peripherally inserted central catheters (PICCs) positioned by the IC-ECG method.
We randomized 2250 patients who needed PICC placement to either a landmark length estimation supplemented by IC-ECG positioned group (ECG group) or the traditional landmark length estimation alone group (control group) in a 2:1 allocation. Post-procedural chest X-rays were applied to confirm tip position. Follow-up was performed monthly to six months. Standard statistics analyses were performed with the SAS 9.13 software, and p < 0.05 was considered significant.
As evaluated by post-procedural chest X-ray, tip location in the ECG group had a first-attempt success (catheter tip located at optimal position) of 91.7% (95% confidence interval (CI): 90.3%-93.1%), significantly higher than 78.9% (95% CI: 76.0%-81.9%) observed in the control group (p < 0.001). At six-month follow-up, in the control group, frequency of total complications was 9.5%, including the exit site infection (4.0%), phlebitis (1.3%), deep venous thrombosis (1.5%), liquid extravasation (2.9%) and mechanical failure (1.9%). The IC-ECG group had significantly lower rates of complications (6.4%, p < 0.001), including the exit site infection (2.7%, p > 0.05), phlebitis (1.1%, p > 0.05), deep venous thrombosis (1.2%, p > 0.05), liquid extravasation (2.4%, p > 0.05) and mechanical failure (1.2%, p > 0.05). In the univariable logistic regression analysis, ECG method, other diseases and upper arms were the independent protective factors, and the number of adjustment procedures (n ≥ 2) were the independent risk factors of the complications.
The intra-procedural tip location by IC-ECG is more safe and accurate than the traditional method of verifying tip location only post-procedurally, by chest X-ray.
心腔内心电图（IC-ECG）方法已被用于中央静脉通路装置的尖端定位，具有安全、准确和高性价比的优势。然而，长期随访并不常见。本随机临床试验旨在评估通过 IC-ECG 方法定位的外周插入中心导管（PICC）的长期并发症。
我们将需要 PICC 置管的 2250 名患者随机分为地标长度估计加 IC-ECG 定位组（ECG 组）或传统地标长度估计组（对照组），比例为 2:1。术后进行胸部 X 光检查以确认尖端位置。进行每月至 6 个月的随访。采用 SAS 9.13 软件进行标准统计学分析，p<0.05 为差异有统计学意义。
术后胸部 X 光片评估显示，ECG 组尖端位置首次尝试成功率（导管尖端位于最佳位置）为 91.7%（95%置信区间：90.3%-93.1%），明显高于对照组的 78.9%（95%置信区间：76.0%-81.9%）（p<0.001）。在 6 个月的随访中，对照组总并发症发生率为 9.5%，包括出口部位感染（4.0%）、静脉炎（1.3%）、深静脉血栓形成（1.5%）、液体外渗（2.9%）和机械故障（1.9%）。IC-ECG 组并发症发生率明显较低（6.4%，p<0.001），包括出口部位感染（2.7%，p>0.05）、静脉炎（1.1%，p>0.05）、深静脉血栓形成（1.2%，p>0.05）、液体外渗（2.4%，p>0.05）和机械故障（1.2%，p>0.05）。在单变量逻辑回归分析中，ECG 方法、其他疾病和上臂是并发症的独立保护因素，调整程序的数量（n≥2）是并发症的独立危险因素。
与传统的仅通过术后胸部 X 光验证尖端位置的方法相比，IC-ECG 术中尖端定位更安全、准确。
