Vascular AccessNIce-PICCNCT06979128
PICC Inserted by a Nurse-led Vascular Access Team in Poland
An observational study of Vascular Access and PICC Line Placement, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access, PICC Line Placement
- What is being tested?
- PICC placement
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 5 May 2025to 2 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects patients who require a PICC
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- PICC placement
- Keywords
- PICC, peripherally inserted central catheter, chest x-ray, PICC tip navigation, nurse, vascular access team
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICC placementProcedure or surgery
Patient scheduled for PICC placement
| Study group | Role | What they receive |
|---|---|---|
| Patients who requrie a PICC | All subjects patients who requrie a PICC Receives: Procedure: PICC placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success rate
First attempt vein puncture defined as single vein puncture and possibility of blood aspiration.
Measured: During placement
Secondary outcomes (6)
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
Once the PICC placement is inserted, confirmation of catheter tip location 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. The number of adjustments to the inserted PICC needed to achieve proper tip location will be recorded
Measured: During placement
Percent of PICCs that remain in place through the required therapy time period
PICCs remaining in place through the required therapy time period were defined as PICCs that were either still in place at the end of the 90-day observation or had been removed because the therapy was completed (end of useful medical use), changed or cancelled.
Measured: 90 days
Incidence of symptomatic venous thrombosis in patients with a PICC
Incidence of symptomatic venous thrombosis defined as any new occurrence of symptomatic venous thrombosis defined by thrombus presence by ultrasonography or other imaging.
Measured: 90 days
Incidence of Catheter-related Bloodstream Infection
Incidence of Catheter-related bloodstream infection where Catheter-related bloodstream infection is defined as positive blood culture(s) with a pathogen not related to another source or positive blood culture(s) with pathogen matching catheter tip culture or blood cultures from peripheral venous puncture and PICC positive with the same pathogen.
Measured: 90 days
Occurrence of complications not directly related to the cannulation procedure
Incidence of phlebitis where phlebitis is defined inflammation of the cannulated vessel identified by redness, swelling, warmth, tenderness, and/or cord formation.
Incidence of extravasation where extravasation is defined as accidental infiltration of a vesicant or chemotherapeutic drug into the tissue around the catheter.
Incidence of local infection where local infection is defined as presence of pus at the exit site and/or culture confirmed site infection.
Incidence of accidental dislodgement where accidental dislodgement is defined as catheter accidentally dislodged the extent to which it requires replacement.
Measured: 90 days
PICC lumen patency
Once the PICC placement is complete, the operator will confirm patency by aspirating each lumen for blood return and flushing each lumen with at least 10 mL of 0.9% NaCl.
For inpatients, each lumen will be assessed for patency at least every 24 hours and/or before administration of medicines. Patency observations will be documented.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start5 May 2025
- Primary completion31 Jan 2026
- Study completion2 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979128
- Sponsor's protocol ID
- KB/35/2025
- Acronym
- NIce-PICC
- Status last verified
- Mar 2026
- First submitted
- 7 May 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PICC Inserted by a Nurse-led Vascular Access Team in Poland
- ClinicalTrials.gov ID
- NCT06979128
- Acronym / sponsor ID
- NIce-PICC / KB/35/2025
- Conditions
- Vascular Access, PICC Line Placement
- Keywords
- PICC, peripherally inserted central catheter, chest x-ray, PICC tip navigation, nurse, vascular access team
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 2 May 2026 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who requrie a PICC | – | Procedure: PICC placementAll subjects patients who requrie a PICC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects patients who require a PICC
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICC placementPatient scheduled for PICC placement | Procedure or surgery | Patients who requrie a PICC |
Primary outcome
First attempt success rate
Time frame: During placement
First attempt vein puncture defined as single vein puncture and possibility of blood aspiration.
6 secondary outcomes
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
Time frame: During placement
Percent of PICCs that remain in place through the required therapy time period
Time frame: 90 days
Incidence of symptomatic venous thrombosis in patients with a PICC
Time frame: 90 days
Incidence of Catheter-related Bloodstream Infection
Time frame: 90 days
Occurrence of complications not directly related to the cannulation procedure
Time frame: 90 days
PICC lumen patency
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Vascular Access
Not yet recruiting
Impact of a Long Peripheral Venous Catheter Protocol in Pediatric and Neonatal Care
Vascular Access Devices, Vascular Access
Recruiting
DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention
Vascular Access Site Occlusion
RecruitingObservational study
A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices
Vascular Access Device
Not yet recruiting
Safety and Effectiveness Clinical Study of Novelrad Vascular Closure System (NVCS)
Vascular Closure Device, Femoral Arteriotomy Closure
Not yet recruiting
A Study of a Device That Helps Place Dialysis Needles
Dialysis, Cannulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Access and PICC Line Placement, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First attempt success rate (time frame: During placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.