Purpose To determine whether the use of a magnetic tracking and electrocardiography-guided catheter tip confirmation system (TCS) is safe and noninferior to fluoroscopy concerning positioning accuracy of a peripheral inserted central catheter (PICC). Methods In this prospective, randomized, single-center study, adult patients scheduled for PICC insertion were assigned 1:1 either to TCS or fluoroscopy. The primary objective was a noninferiority comparison of correct PICC tip position confirmed by X-ray obtained immediately after catheter insertion. Time needed for PICC insertion and insertion-related complications up to 14 days after the procedure were secondary outcomes to be assessed for superiority. Results A total of 210 patients (62.3 ± 14.4 years, 63.8% male) were included at a single German center between June 2016 and October 2017. Correct PICC tip position was achieved in 84 of 103 TCS (82.4%) and 103 of 104 fluoroscopy patients (99.0%). One-sided 95% lower confidence limit on the difference between proportions was −23.1%. Thus, noninferiority of TCS was not established (p > 0.99). Insertion of PICC took longer with TCS compared to fluoroscopy (8.4 ± 3.7 min vs. 5.0 ± 2.7 min, p < 0.001). Incidence of complications within a mean follow-up of 5.0 ± 2.3 days did not differ significantly between groups. Conclusion Noninferiority of TCS to fluoroscopy in the incidence of correct PICC tip position was not reached. Ancillary benefit of TCS over fluoroscopy including less radiation exposure and lower resource requirements may nonetheless justify the use of TCS. The study is registered with Clinical.Trials.gov (Identifier: NCT02929368).

Purpose To assess the effectiveness and safety of the over-the-wire (OTW) technique as compared to the direct catheter insertion (DCI) technique in ultrasound (US) guided peripherally inserted central venous catheter (PICC) placement with fluoroscopic catheter tip location.Methods In a non-inferiority randomized-controlled study, 60 PICCs were implanted by an interventional radiologist into the basilic, cephalic, or brachial vein of the mid-upper arm. The effectiveness as primary endpoint was measured by implantation time. Placement accuracy was detected as secondary endpoint by tip location under chest x-ray, whereas safety was measured by the rate of periprocedural and early complications occurring within two weeks. Results Implantation time of 8.34 ± 2.14 minutes applying the OTW technique showed to be significantly more time-consuming than DCI technique with 5.530.96 minutes (p<0.001). The results for the secondary endpoints were not allowing a statistically significant statement due to the patient number. The exploratory analysis showed however no significant difference (p=0.3) regarding tip placement accuracy between both insertion techniques (optimal tip localization of 100% with the DCI technique; 97% with the OTW technique). Periprocedural bleeding events from the introducer occurred in 26.7% of the patients with OTW technique towards not considerable bleeding in the DCI group (p=0.003). Conclusion For US-guided fluoroscopic PICC insertion in adults, the DCI technique was superior as compared to the OTW technique in terms of procedure time.Trial registration NCT 04303052