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

NCT07791719 | Not Yet Recruiting

• 1 other identifier: Different PICC catheterization
• Study Type: interventional
• Target: 801
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Patients

Keywords

Peripherally inserted central catheters ; tunneled; complications

Outcome Measures

Primary Outcomes (1)

• Overall Incidence of Catheter-Related Complications Within 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.

  From catheterization to 90 days post-catheterization

Secondary Outcomes (5)

• One-Time Puncture Success Rate

  Day 1 During catheterization procedure

• Pain Intensity During Catheterization (NRS Score)

  Day 1 Immediately after catheterization procedure

• Intraoperative Bleeding Volume

  Day 1 From start to end of catheterization procedure

• Catheterization Procedure Time

  Day 1 During catheterization procedure

• Unplanned Catheter Removal Rate

  From Day 1 catheterization to 90 days post-catheterization

Study Arms (3)

Conventional Non-Tunneled PICC catheterization

ACTIVE COMPARATOR

Patients receive conventional non-tunneled PICC insertion. The procedure involves ultrasound-guided vein puncture, guidewire insertion, local anesthesia and skin dilation, followed by sheath and catheter advancement. The catheter exit site is at the puncture site.

Procedure: Conventional Non-Tunneled PICC catheterization

One-Needle Tunneled PICC catheterization

EXPERIMENTAL

Patients receive one-needle tunneled PICC insertion. The puncture needle travels subcutaneously for 4 cm before entering the vessel, creating a subcutaneous tunnel. The skin puncture and catheter exit sites are the same. This technique requires only one needle pass for both tunneling and vessel puncture.

Procedure: One-Needle Tunneled PICC catheterization

Two-Needle Tunneled PICC catheterization

EXPERIMENTAL

Patients receive two-needle tunneled PICC insertion. Ultrasound-guided vein puncture is performed first, followed by creation of a 4 cm subcutaneous tunnel using a tunneling tool. The puncture site and catheter exit site are separate, with a subcutaneous tunnel connecting them.

Procedure: Two-Needle Tunneled PICC catheterization

Interventions

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.

Conventional Non-Tunneled PICC catheterization

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.

One-Needle Tunneled PICC catheterization

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.

Two-Needle Tunneled PICC catheterization

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Central Study Contacts

Zeyin Hu

CONTACT

86+15899954190; huzy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist nurse

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 10, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

CN (1)