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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer Patients
• Intervention / Treatment: Procedure: Conventional Non-Tunneled PICC catheterization; Procedure: One-Needle Tunneled PICC catheterization; Procedure: Two-Needle Tunneled PICC catheterization

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 801
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zeyin Hu; Phone Number: 86+15899954190; Email: huzy@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-Sen University Cancer Center
      • Contact: Jiasheng Huang; Phone Number: 86+17602023464; Email: huangjs1@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Non-Tunneled PICC catheterization; 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; 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.
Experimental: One-Needle Tunneled PICC catheterization; 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; 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.
Experimental: Two-Needle Tunneled PICC catheterization; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
One-Time Puncture Success Rate	Proportion of patients in whom the first puncture successfully enters the vein and the guidewire is smoothly advanced.	Day 1 During catheterization procedure
Pain Intensity During Catheterization (NRS Score)	Pain level assessed using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) immediately after catheterization.	Day 1 Immediately after catheterization procedure
Intraoperative Bleeding Volume	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).	Day 1 From start to end of catheterization procedure
Catheterization Procedure Time	Time from the first skin puncture to the moment the catheter is delivered to the predetermined length.	Day 1 During catheterization procedure
Unplanned Catheter Removal Rate	Proportion of catheters removed prematurely due to complications (e.g., infection, thrombosis, dislodgement, occlusion) before the completion of treatment.	From Day 1 catheterization to 90 days post-catheterization

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): September 10, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: August 25, 2026
• First Submitted That Met QC Criteria: August 25, 2026
• First Posted (Actual): August 28, 2026

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 25, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Peripherally inserted central catheters ; tunneled; complications
• Other Study ID Numbers: Different PICC catheterization

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No