PICC-associated Thrombosis, PICC Line Placement
Conditions
Keywords
tunnel, PICC, complications, thrombosis, infection, bleeding
Brief summary
This prospective randomized controlled trial compares the effectiveness and safety of one-needle and two-needle tunneling techniques for peripherally inserted central catheter (PICC) placement, aiming to identify the optimal tunneling method to reduce catheter-related complications.
Interventions
OTHEROne-needle tunnel technique
1. Local anesthesia is administered at the puncture site，Ultrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation，the puncture needle travels 4 cm through the subcutaneous tissue before entering the blood vessel; 2. The guide wire is inserted along the puncture needle; 3. skin dilation; 4. The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath; 5. The catheter tip position is confirmed, and the catheter is secured.
OTHERtwo-needle tunnel technique
Two-needle tunnel PICC procedure: 1. Local anesthesia at puncture and catheter exit sites; 2. Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle; 3. Skin dilation at both puncture and exit sites; 4. 4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution; 5. Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site; 6. Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal; 7. Vascular sheath peeled off, catheter adjusted to proper position; 8. Catheter tip position confirmed; 9. Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 and 75 years old; * Educational level of primary school or above, with basic listening, speaking, reading and writing abilities, and capable of completing the questionnaire independently; * Receiving tunneled PICC catheterization for the first time, with 4Fr single-lumen solo PICC catheter indwelling; * Able to attend regular PICC maintenance at our hospital as scheduled after catheterization; * Voluntarily participate in this study and sign the informed consent form for this study as well as the informed consent form for PICC catheterization.
Exclusion criteria
* Patients with coagulation dysfunction (INR \> 1.5 / PLT \< 50×10⁹/L); * Pregnant or lactating women; * Patients with BMI \< 18.5 kg/m²; * Patients receiving PICC catheterization via lower extremity veins; * Patients with known or suspected allergy to components of PICC catheters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall PICC-related complications after catheter placement | 4 weeks after PICC placement | these complications include catheter exit site oozing, contact dermatitis, venous thrombosis, infection, catheter displacement or dislodgement, mechanical phlebitis, catheter occlusion, and catheter fracture or damage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| first-puncture success rate of PICC catheterization | day 1 during PICC catheterization | — |
| pain score | Day 1 during PICC placement | Evaluated by Numerical Rating Scale , a self-report tool where individuals rate their pain intensity from 0 (no pain) to 10 (worst possible pain)，with higher scores indicating more severe pain. |
| Bleeding during PICC placement | Day 1 during PICC placement | — |
| unplanned catheter removal rate of PICC | 4 weeks after PICC placement | — |
Countries
China
Contacts
CONTACTZeyin Hu
Outcome results
None listed