Introduction: 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. Methods: 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. Results: 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). Conclusion: 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.

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Background 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. Methods 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. Results 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. Conclusions 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.