Effects of Different Tunnel Methods in PICC Catheterization
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
One-needle tunnel technique
Other intervention1. 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.
two-needle tunnel technique
Other interventionTwo-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.
Treatment groups
284 Participants
are divided into 2 treatment groupsGroup A: cancer patients who undergo PICC placement using two-needle tunnel techniqueActive comparator 1 intervention
Group B: cancer patients who undergo PICC placement using one-needle tunnel techniqueExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
overall PICC-related complications after catheter 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.
Time frame
4 weeks after PICC placementSecondary outcomes
1
first-puncture success rate of PICC catheterization
Time frame
day 1 during PICC catheterization2
pain score
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.
Time frame
Day 1 during PICC placement3
Bleeding during PICC placement
Time frame
Day 1 during PICC placement4
unplanned catheter removal rate of PICC
Time frame
4 weeks after PICC placementSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov