Recruiting NCT07594704
Effects of Different Tunnel Methods in PICC Catheterization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: One-needle tunnel technique, two-needle tunnel technique.
- Who it may be relevant to
- Registry conditions: PICC Line Placement, PICC-associated Thrombosis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Different Tunnel Methods in PICC Catheterization: A Randomized Controlled Trial
Overview
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.
Interventions
- Other One-needle tunnel technique
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, - Other two-needle tunnel technique
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 sheat
Primary outcome measures
- overall PICC-related complications after catheter placement [Time frame: 4 weeks after PICC placement]
Secondary outcome measures (4)
- first-puncture success rate of PICC catheterization [Time frame: day 1 during PICC catheterization]
- pain score [Time frame: Day 1 during PICC placement]
- Bleeding during PICC placement [Time frame: Day 1 during PICC placement]
- unplanned catheter removal rate of PICC [Time frame: 4 weeks after PICC placement]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07594704 · B2026-068-01