Clinical trial NCT06979128: PICC Inserted by a Nurse-led Vascular Access Team in Poland
Official title: PICC Inserted by a Nurse-led Vascular Access Team in Poland
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vascular Access
PICC Line Placement
Keywords: PICC
peripherally inserted central catheter
chest x-ray
PICC tip navigation
nurse
vascular access team
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects patients who require a PICC

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).

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

Primary outcomes:
measure: First attempt success rate
timeFrame: During placement
Secondary outcomes:
measure: Confirmation of tip placement in the lower 1/3 of the superior vena cava at or above the superior vena cava/right atrium junction will be performed by chest x-ray or other tip confirmation system/device and documented
timeFrame: During placement
measure: Percent of PICCs that remain in place through the required therapy time period
timeFrame: 90 days
measure: Incidence of symptomatic venous thrombosis in patients with a PICC
timeFrame: 90 days
measure: Incidence of Catheter-related Bloodstream Infection
timeFrame: 90 days
measure: Occurrence of complications not directly related to the cannulation procedure
timeFrame: 90 days
measure: PICC lumen patency
timeFrame: 90 days
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
Study officials:
References: