Effects of Different Tunnel Methods in PICC Catheterization

Effects of Different Tunnel Methods in PICC Catheterization: A Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: PICC Line Placement; PICC-associated Thrombosis
• Intervention / Treatment: Other: two-needle tunnel technique; Other: One-needle tunnel technique

• Study Type: Interventional
• Enrollment (Estimated): 284
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zeyin Hu; Phone Number: 15899954190; Email: huzy@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun yat-sen University Cancer Center
      • Contact: Zeyin Hu; Phone Number: 15899954190; Email: huzy@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cancer patients who undergo PICC placement using two-needle tunnel technique; Two-needle tunnel PICC procedure: Local anesthesia at puncture and catheter exit sites;; Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle;; Skin dilation at both puncture and exit sites;; 4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution;; Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site;; Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal;; Vascular sheath peeled off, catheter adjusted to proper position;; Catheter tip position confirmed;; Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured.	Other: two-needle tunnel technique; Two-needle tunnel PICC procedure: Local anesthesia at puncture and catheter exit sites;; Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle;; Skin dilation at both puncture and exit sites;; 4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution;; Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site;; Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal;; Vascular sheath peeled off, catheter adjusted to proper position;; Catheter tip position confirmed;; Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured.
Experimental: cancer patients who undergo PICC placement using one-needle tunnel technique; Ultrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation: Local anesthesia is administered at the puncture site，the puncture needle travels 4 cm through the subcutaneous tissue before entering the blood vessel;; The guide wire is inserted along the puncture needle;; skin dilation;; The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath;; The catheter tip position is confirmed, and the catheter is secured.	Other: One-needle tunnel technique; 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;; The guide wire is inserted along the puncture needle;; skin dilation;; The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath;; The catheter tip position is confirmed, and the catheter is secured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks after PICC placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first-puncture success rate of PICC catheterization		day 1 during PICC catheterization
Bleeding during PICC placement		Day 1 during PICC placement
unplanned catheter removal rate of PICC		4 weeks after PICC placement
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.	Day 1 during PICC placement

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: complications; bleeding; infection; thrombosis; PICC; tunnel
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Embolism and Thrombosis; Pathological Conditions, Signs and Symptoms; Thrombosis; Infections; Hemorrhage
• Other Study ID Numbers: B2026-068-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No