Image-Guided Central Catheter Insertion With Concurrent Assessment of Vascular Wall Integrity

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Centre Ljubljana

About this trial

The insertion of peripherally inserted central catheters (PICCs) represents a minimally invasive and safe method for establishing long-term central venous access in patients requiring prolonged intravenous therapy, including chemotherapy, parenteral nutrition, and long-term antibiotic treatment. Ultrasound-guided cannulation of peripheral arm veins improves procedural success, reduces complications, and increases patient comfort compared with centrally inserted central catheters.Accurate positioning of the catheter tip at the cavo-atrial junction is essential for optimal catheter function and safety. The Sherlock 3CG Tip Confirmation System combines electromagnetic tracking with intracavitary electrocardiography (ECG) to enable real-time catheter tip navigation and positioning.The aim of this prospective clinical study is to evaluate the accuracy and safety of ultrasound-guided PICC insertion using the Sherlock 3CG system, as well as to assess the impact of PICC placement on venous wall integrity. Ultrasound examination of the target vein will be performed before catheter insertion and after catheter removal to evaluate potential vascular wall changes associated with catheter use. A chest X-ray examination will be performed after each catheter insertion to confirm final catheter tip position and to assess the accuracy of the navigation system.Fluoroscopic guidance will be used only in selected cases, such as patients with anatomical anomalies, previously known difficult vascular access, or unsuccessful standard catheter advancement.A total of 80 adult patients with a clinical indication for PICC placement will be enrolled over a three-year study period.

Eligibility criteria

Qualifiers

sinus rhythm

medical indication

suitable upper-extremity venous anatomy confirmed by ultrasound examination

ability to provide written informed consent

Disqualifiers

Implanted cardiac pacing device

Palliative care

<18years old

Local infection, skin lesion, or burn at the intended insertion site

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

80 Participants
are grouped into 1 trial group

Locations

This trial has no locations

Sponsors and collaborators

University Medical Centre Ljubljana

Lead sponsor

Institute of Oncology Ljubljana

Collaborator