Infraclavicular subclavian vein catheterisation: a randomised controlled trial comparing standard ultrasound guidance and a new needle guidance device

Background: The infraclavicular subclavian approach for central venous catheterisation is associated with approximately twofold lower infectious and thrombotic complication rates than the jugular and femoral sites, yet remains underutilised because of perceived technical difficulty. We assessed whether real-time magnetic needle-tracking improves procedural success and security compared to standard ultrasound guidance. Methods: In this single-centre, randomised controlled trial, ICU patients requiring subclavian catheterisation were randomly assigned (1:1) to magnetic needle-tracking or standard ultrasound guidance. The primary outcome was uncomplicated first-puncture success. Secondary outcomes included a composite of immediate mechanical complications and procedure failures, and subgroups were pre-specified by ventilation status. Results: Among 124 randomised (mean age 60 years; 73% mechanically ventilated), 120 completed the procedure. Uncomplicated first-puncture success occurred in 47/57 patients (82.5%) with magnetic-tracking and 44/63 (69.8%) with the standard ultrasound group (absolute difference, +12.6%; p = 0.053). Magnetic tracking reduced the composite complication outcome (8.8% versus 22.2%; absolute difference, −13.5%; p = 0.044). In the pre-specified subgroup of spontaneously breathing patients (n = 31), magnetic tracking was associated with a substantial but non-significant improvement in the primary outcome (85.7% versus 52.9%; absolute difference, +32.8%; p = 0.058) and shortened catheterisation duration (p = 0.027). These differences were not observed in mechanically ventilated patients. Conclusions: In ICU patients undergoing subclavian catheterisation, magnetic needle-tracking did not significantly increase overall uncomplicated first-puncture success but reduced the incidence of immediate mechanical complications and procedure failures, with a substantial effect in spontaneously breathing patients. These findings warrant confirmation but support further evaluation of magnetic navigation as an adjunct to standard ultrasound guidance. © 2026 The Author(s). Published by Elsevier Masson SAS on behalf of Société Française d'Anesthésie et de Réanimation (SFAR). This is an open access article under the CC BY license. http://creativecommons.org/licenses/by/4.0/