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NCT Number: NCT07791719

Effects of Different PICC Catheterization Methods: A Multicenter Randomized Controlled Trial

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.

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Key information

Conditions

Cancer Patients

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 contact

Jiasheng Huang

CONTACT

[email protected]

86+17602023464

About this study

This study adopts a prospective, multicenter, three-arm, parallel-group randomized controlled design. A total of 801 patients will be recruited from 11 hospitals and randomly assigned in a 1:1:1 ratio to the three groups. The control group receives conventional non-tunneled PICC insertion. Experimental group 1 receives one-needle tunneled insertion (the needle travels subcutaneously for 4 cm before entering the vessel). Experimental group 2 receives two-needle tunneled insertion (with a 4 cm subcutaneous tunnel created using a tunneling tool). All insertions are performed by certified PICC nurses with over 5 years of experience who have received standardized training. The primary outcome is the overall incidence of catheter-related complications within 90 days post-insertion. Secondary outcomes include one-time puncture success rate, NRS pain score, intraoperative bleeding volume, catheterization time, and unplanned catheter removal rate. Outcome assessors and data analysts are blinded to group allocation. The study has been approved by the Ethics Committee of Sun Yat-sen University Cancer Center (Approval No. B2026-467-01, dated August 10, 2026).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • Willing to participate in the study and sign the informed consent form and PICC insertion consent form

Exclusion criteria

  • 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
  • Patients requiring lower extremity PICC insertion
  • Known or suspected allergy to components of the PICC catheter

Treatment and study plan

Conventional Non-Tunneled PICC catheterization

Procedure

Ultrasound-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

The 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

A 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.

Primary outcomes

  1. Overall Incidence of Catheter-Related Complications Within 90 Days Post-catheterization

    Time frame: From catheterization to 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.

Secondary outcomes

  1. One-Time Puncture Success Rate

    Time frame: Day 1 During catheterization procedure

    Proportion of patients in whom the first puncture successfully enters the vein and the guidewire is smoothly advanced.

  2. Pain Intensity During Catheterization (NRS Score)

    Time frame: Day 1 Immediately after catheterization procedure

    Pain level assessed using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) immediately after catheterization.

  3. Intraoperative Bleeding Volume

    Time frame: Day 1 From start to end of catheterization procedure

    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).

  4. Catheterization Procedure Time

    Time frame: Day 1 During catheterization procedure

    Time from the first skin puncture to the moment the catheter is delivered to the predetermined length.

  5. Unplanned Catheter Removal Rate

    Time frame: From Day 1 catheterization to 90 days post-catheterization

    Proportion of catheters removed prematurely due to complications (e.g., infection, thrombosis, dislodgement, occlusion) before the completion of treatment.

Study contacts

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

Zeyin Hu

CONTACT

[email protected]

86+15899954190

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • First Affiliated Hospital of Jinan University
  • Gansu Hospital of Sun Yat-sen University Cancer Center
  • Haikou People's Hospital
  • Jiangsu Cancer Institute & Hospital
  • Jieyang People's Hospital
  • Renmin Hospital of Wuhan University
  • Shenzhen People's Hospital
  • The First Affiliated Hospital of Nanchang University
  • Wuzhou Red Cross Hospital
  • Zhongshan People's Hospital, Guangdong, China

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Aug 28, 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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