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NCT Number: NCT07594704

Effects of Different Tunnel Methods in PICC Catheterization

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.

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Key information

Conditions

PICC Line Placement Cardiovascular Diseases Embolism and Thrombosis Hemorrhage Infections PICC-associated Thrombosis Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Zeyin Hu

CONTACT

[email protected]

15899954190

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

One-needle tunnel technique

Other
  • 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.

two-needle tunnel technique

Other

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.

Primary outcomes

  1. overall PICC-related complications after catheter placement

    Time frame: 4 weeks after PICC 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.

Secondary outcomes

  1. first-puncture success rate of PICC catheterization

    Time frame: day 1 during PICC catheterization

  2. pain score

    Time frame: Day 1 during PICC placement

    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.

  3. Bleeding during PICC placement

    Time frame: Day 1 during PICC placement

  4. unplanned catheter removal rate of PICC

    Time frame: 4 weeks after PICC placement

Study contacts

Contact information is provided by the study sponsor or research team.

Zeyin Hu

CONTACT

[email protected]

15899954190

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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