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

This trial does not accept healthy volunteers

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 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 1 trial group
Group A: Group

Trial outcomes

Primary outcomes

1

Change in Venous Wall Thickness

Measured in milimeters by high-resolution ultrasound at the catheterized vein

Time frame
Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).

Secondary outcomes

1

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.

Time frame
Immediately after insertion.
2

Procedural Success Rate

Successful catheter placement defined as correct tip location at the cavo-atrial junction without the need for repositioning.

Time frame
During procedure.
3

Procedure Duration

Time from skin puncture to successful catheter placement.

Time frame
Time from skin puncture to successful catheter placement measured in minutes
4

Incidence of Procedure-Related Complications

Complications include: * Arterial puncture * Hematoma * Malposition * Catheter dysfunction * Infection at insertion site * Symptomatic venous thrombosis * Pain requiring intervention

Time frame
From insertion to 24 hours post-procedure and throughout catheter dwell time.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Centre Ljubljana

Lead sponsor

Institute of Oncology Ljubljana

Collaborator

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