Effects of Different PICC Catheterization Methods: A Multicenter Randomized Controlled Trial

Effects of Different PICC Catheterization Methods: A Multicenter Randomized Controlled Trial

This study aims to compare the clinical effectiveness of three PICC (Peripherally Inserted Central Catheter) insertion methods: conventional non-tunneled PICC, one-needle tunneled PICC, and two-needle tunneled PICC. This is a multicenter randomized controlled trial involving 11 hospitals in China, with a total of 801 patients scheduled to undergo PICC insertion for the first time. Patients will be randomly assigned in a 1:1:1 ratio to the three groups. The primary outcome is the incidence of post-insertion complications (including oozing, infection, thrombosis, catheter dislodgement, etc.) within 90 days. Secondary outcomes include one-time puncture success rate, pain level (NRS), bleeding volume, catheterization time, and unplanned catheter removal rate. The results will provide evidence for selecting the optimal PICC insertion method in clinical practice.

This study adopts a prospective, multicenter, three-arm, parallel-group randomized controlled design. A total of 801 patients will be recruited from 11 hospitals and randomly assigned in a 1:1:1 ratio to the three groups. The control group receives conventional non-tunneled PICC insertion. Experimental group 1 receives one-needle tunneled insertion (the needle travels subcutaneously for 4 cm before entering the vessel). Experimental group 2 receives two-needle tunneled insertion (with a 4 cm subcutaneous tunnel created using a tunneling tool). All insertions are performed by certified PICC nurses with over 5 years of experience who have received standardized training. The primary outcome is the overall incidence of catheter-related complications within 90 days post-insertion. Secondary outcomes include one-time puncture success rate, NRS pain score, intraoperative bleeding volume, catheterization time, and unplanned catheter removal rate. Outcome assessors and data analysts are blinded to group allocation. The study has been approved by the Ethics Committee of Sun Yat-sen University Cancer Center (Approval No. B2026-467-01, dated August 10, 2026).

Inclusion Criteria:

• Age 18 to 75 years
• Education level of primary school or above, with adequate reading, writing and --communication skills to independently complete the questionnaire
• First-time PICC insertion using a 4Fr single-lumen solo PICC catheter
• Able to attend follow-up visits at the same hospital for catheter maintenance after insertion
• Willing to participate in the study and sign the informed consent form and PICC insertion consent form

Exclusion Criteria:

• Coagulation dysfunction (INR > 1.5 or PLT < 25 × 10⁹/L)
• Use of anticoagulants (e.g., warfarin, heparin) within 3 days before catheterization
• Pregnant or lactating women
• BMI < 18.5 kg/m²
• Patients requiring lower extremity PICC insertion
• Known or suspected allergy to components of the PICC catheter