Magnetic Tracking and Electrocardiography-Guided Tip Confirmation System Versus Fluoroscopy for Placement of Peripherally Inserted Central Catheters: A Randomized, Noninferiority Comparison

V Mack, D Nißler, D Kasikci, A Malouhi, R Aschenbach, U Teichgräber, V Mack, D Nißler, D Kasikci, A Malouhi, R Aschenbach, U Teichgräber

Abstract

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).

Keywords: Central venous catheterization; Electrocardiography; Fluoroscopy; Peripheral catheterization; Radiation exposure.

Conflict of interest statement

All authors declare that they have no conflict of interest with respect to this article.

Figures

Fig. 1
Fig. 1
The Y-shaped electromagnetic sensor is positioned on the patient’s sternum. Two leads pick up external ECG waveforms (A). The PICC catheter is then inserted through the sheath into the brachial vein and advanced toward the cavoatrial junction (B). Magnets in the stylet of the catheter tip generate a field that is detected by the sensor and thus can be tracked in real time on the display (circle). The display also shows ECG waves from skin and catheter tip (C). Circle turns into rhombus and p-waves are highlighted when the catheter tip reaches the cavoatrial junction (D)
Fig. 2
Fig. 2
Patient flow. ITT intention to treat, PICC peripherally inserted central catheter, TCS tip confirmation system
Fig. 3
Fig. 3
Subgroup analysis of correct tip location (primary endpoint) depending on patient characteristics. Continuous lines show overall treatment effect point and no effect point, respectively. Dotted line indicates noninferior margin. BMI body mass index, TCS tip confirmation system

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