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

NCT07466472 | Not Yet Recruiting

• 2 other identifiers: 20250214Medical Center Ljubljana
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

PICC Line Placement; Vessels; Anomaly

Keywords

PICC; Sherlock 3CG; Vessels Anomaly; Vessel Wall; Intracavitary Electrocardiogram

Outcome Measures

Primary Outcomes (1)

• Change in Venous Wall Thickness

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

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

Secondary Outcomes (9)

• Accuracy of Catheter Tip Positioning Using Sherlock 3CG

  Immediately after insertion.

• Procedural Success Rate

  During procedure.

• Procedure Duration

  Time from skin puncture to successful catheter placement measured in minutes

• Incidence of Procedure-Related Complications

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

• Need for Fluoroscopy Guidance

  During procedure.

Study Arms (1)

Group

All patients will undergo ultrasound-guided PICC insertion using the Sherlock 3CG Tip Confirmation System, which combines electromagnetic tracking with intracavitary ECG guidance. • Post-procedural chest X-ray will be performed after each insertion to confirm catheter tip position and evaluate system accuracy. • Fluoroscopy will only be used in exceptional cases, such as known anatomical anomalies or previously documented difficult venous access.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• sinus rhythm
• medical indication
• suitable upper-extremity venous anatomy confirmed by ultrasound examination
• ability to provide written informed consent

You may not qualify if:

• Implanted cardiac pacing device
• Palliative care
• \<18years old
• Local infection, skin lesion, or burn at the intended insertion site
• Severe coagulopathy contraindicating vascular access procedures
• Known allergy to catheter materials or local anesthetics used during the procedure
• Presenceof an implanted cardiac pacemaker or non-sinus cardiac rhythm preventing reliable intracavitary ECG guidance
• Anatomical abnormalities preventing safe PICC insertion
• Previous lymphadenectomy on the intended side
• Pre-existing venous thrombosis or significant venous wall pathology detected on baseline ultrasound

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Institute of Oncology Ljubljana: collaborator

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dimitrij Kuhelj, MD, PhD

  University Medical Center Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrij Kuhelj Associate Professor MD, Senior Consultant, MD, PhD

CONTACT

• 0038615228530; dimitrij.kuhelj@kclj.si

Alen Mahmutović Assistant, Bsc, Msc in Nursing, RN, B.A.Sc., M.Sc.

CONTACT

0038670649693; alen.mahmutovic@zf.uni-lj.si

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-02