Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who requrie a PICC | All subjects patients who requrie a PICC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICC placement | Procedure | Patient scheduled for PICC placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| First attempt success rate | First attempt vein puncture defined as single vein puncture and possibility of blood aspiration. | During placement |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All subjects patients who require a PICC
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Warsaw | Warsaw | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002406 | Catheterization, Peripheral |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | 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. | 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. | 90 days |
| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |