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

NCT07594704 | Recruiting DMC

• 1 other identifier: B2026-068-01
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PICC Line Placement; PICC-associated Thrombosis

Keywords

tunnel; PICC; complications; thrombosis; infection; bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• first-puncture success rate of PICC catheterization

  day 1 during PICC catheterization

• pain score

  Day 1 during PICC placement

• Bleeding during PICC placement

  Day 1 during PICC placement

• unplanned catheter removal rate of PICC

  4 weeks after PICC placement

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Other: two-needle tunnel technique

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

EXPERIMENTAL

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.

Other: One-needle tunnel technique

Interventions

One-needle tunnel technique OTHER

1. 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; 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.

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

two-needle tunnel technique OTHER

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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Thrombosis; Infections; Hemorrhage

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zeyin Hu

CONTACT

15899954190; huzy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Researcher

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-04

Locations

CN (1)