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
This trial does not accept healthy volunteersQualifiers
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 population
Adult patients (\>18years) with sinus rhythm in the absence of an implanted cardiac pacing device and a medical indications for PICC placement, including oncologic therapy, parenteral nutrition, or prolonged intravenous treatment, will be considered eligible for participation. All participants will provide written informed consent prior to enrollment.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in Venous Wall Thickness
Measured in milimeters by high-resolution ultrasound at the catheterized vein
Secondary outcomes
Accuracy of Catheter Tip Positioning Using Sherlock 3CG
Accuracy of PICC tip placement will be evaluated by comparing the tip location predicted by the Sherlock 3CG system with chest X-ray confirmation performed after each insertion.
Procedural Success Rate
Successful catheter placement defined as correct tip location at the cavo-atrial junction without the need for repositioning.
Procedure Duration
Time from skin puncture to successful catheter placement.
Incidence of Procedure-Related Complications
Complications include: * Arterial puncture * Hematoma * Malposition * Catheter dysfunction * Infection at insertion site * Symptomatic venous thrombosis * Pain requiring intervention
Locations
Sponsors and contacts
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University Medical Centre Ljubljana
Lead sponsor
Institute of Oncology Ljubljana
Collaborator
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