Effects of Different Tunnel Methods in PICC Catheterization

Sun Yat-sen University

Status: Enrolling

Conditions: PICC-associated Thrombosis; PICC Line Placement

Treatments: Other: One-needle tunnel technique; Other: two-needle tunnel technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07594704

B2026-068-01

Details and patient eligibility

About

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.

Enrollment: 284 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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284 participants in 2 patient groups

cancer patients who undergo PICC placement using two-needle tunnel technique

Active Comparator group

Description:

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.

Treatment:

Other: two-needle tunnel technique

cancer patients who undergo PICC placement using one-needle tunnel technique

Experimental group

Description:

Ultrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation: 1. Local anesthesia is administered at the puncture site，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.

Treatment:

Other: One-needle tunnel technique