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.
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
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
Parallel
Conventional Non-Tunneled PICC catheterization
Procedure/SurgeryUltrasound-guided vein puncture, followed by guidewire insertion, local anesthesia, skin dilation, sheath advancement, and catheter delivery. The catheter exit site is at the puncture site with no subcutaneous tunnel created.
One-Needle Tunneled PICC catheterization
Procedure/SurgeryThe puncture needle travels subcutaneously for 4 cm before entering the vessel, creating a subcutaneous tunnel with a single needle pass. The puncture site and catheter exit site are the same. This technique combines tunneling and vessel puncture in one step.
Two-Needle Tunneled PICC catheterization
Procedure/SurgeryA two-step procedure: first, ultrasound-guided vein puncture is performed; then, a separate subcutaneous tunnel of 4 cm is created using a tunneling tool. The puncture site and catheter exit site are separate, connected by a subcutaneous tunnel. The catheter is pulled through the tunnel from the exit site to the puncture site.
Overall Incidence of Catheter-Related Complications Within 90 Days Post-catheterization
The composite endpoint includes: oozing/exudation at the catheter exit site, mechanical phlebitis, catheter-related bloodstream infection, local or tunnel infection, catheter-related thrombosis, catheter dislodgement or migration, catheter occlusion, contact dermatitis, and catheter breakage or damage. All complications are assessed from the day of insertion up to 90 days post-insertion.
One-Time Puncture Success Rate
Proportion of patients in whom the first puncture successfully enters the vein and the guidewire is smoothly advanced.
Pain Intensity During Catheterization (NRS Score)
Pain level assessed using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) immediately after catheterization.
Intraoperative Bleeding Volume
Total bleeding volume during catheterization, calculated by weighing gauze pads before and after the procedure (converted using whole blood specific gravity of 1.05 g/mL).
Catheterization Procedure Time
Time from the first skin puncture to the moment the catheter is delivered to the predetermined length.
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Sun Yat-sen University
Lead sponsor
Gansu Hospital of Sun Yat-sen University Cancer Center
Collaborator
Shenzhen People's Hospital
Collaborator
Zhongshan People's Hospital, Guangdong, China
Collaborator
First Affiliated Hospital of Jinan University
Collaborator
Haikou People's Hospital
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Jiangsu Cancer Institute & Hospital
Collaborator
Wuzhou Red Cross Hospital
Collaborator
Renmin Hospital of Wuhan University
Collaborator
Jieyang People's Hospital
Collaborator
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