PICC Inserted by a Nurse-led Vascular Access Team in Poland

NCT ID: NCT06979128

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2026-08-01

Brief Summary

Implantation of PICCs by a trained, dedicated nursing team can be effective and safe, and allows for intravenous therapy that requires medium- to long-term central venous access.

Detailed Description

The insertion of Peripherally Inserted Central Catheters (PICCs) offers numerous advantages over direct puncture of central veins. Ultrasound-guided insertion of PICCs into the peripheral vein is characterized by the high efficiency and safety of the procedure as well as patient comfort, and is a safe alternative to centrally inserted central catheters (CICCs) associated with a lower risk of complications. The PICCs will be inserted into one of the veins of the arm (basilic, brachial, cephalic) under ultrasound guidance. Cannulation will be supervised by a physician. Prior to cannulation a local anesthetic drug will be applied to the site of the planned puncture. Each PICC cannulation set consists of an echogenic needle, a guidewire, an introducer, a catheter with a diameter of 4 or 5 Fr and a length of 50-60 cm, a adhesive sutureless fixation, a semi-permeable transparent dressing, a needleless connector and a sticker indicating the type of vascular access. During the procedure intracavitary ECG will be used to catheter tip navigation. After the procedure, a chest X-ray will be taken to document the correct position of the tip. Taking into account the experience of the researchers and the learning curve described in the literature, it is planned to perform 200 PICC insertion procedures during the study period (50 per operator).

Conditions

Vascular Access; PICC Line Placement

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients who requrie a PICC

All subjects patients who requrie a PICC

PICC placement

Intervention Type: PROCEDURE

Patient scheduled for PICC placement

Interventions

PICC placement

Patient scheduled for PICC placement

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age >18 years
• Intravenous therapy with solutions requiring central vein cannulation (irritant drugs, extreme pH <5 and >9, osmolarity > 600 mOsm/l), e.g., chemotherapy, parenteral nutrition with osmolarity >900 mOsm/l
• Difficult intravenous access with multiple blood collection
• Ability to consent to participate in the study
• Consent to participate in the study

Exclusion Criteria

• Presence of central venous catheter, such as. centrally inserted central catheter or totally implanted vascular device
• Indication of another type of vascular access device
• Lack of veins suitable for cannulation of the arm
• Infection, burns or other skin lesion on the upper extremities (involving the site of planned catheter insertion and attachment)
• Pregnancy (confirmed by history and review of medical records or confirmed by positive human chorionic gonadotropin (hCG) determination in urine or plasma)
• Lack of patient consent to participate in the study
• Lack of capacity to consent to participate in the study
• No physician present to supervise the procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Warsaw

Warsaw, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Dr Maciej Latos

Role: CONTACT

maciej.latos@wum.edu.pl

48601292532

Facility Contacts

Dr Maciej Latos

Role: primary

maciej.latos@wum.edu.pl

48601292532

Other Identifiers

KB/35/2025

Identifier Type: -

Identifier Source: org_study_id