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

N/ANot Yet RecruitingNCT07791719

Sun Yat-sen University801 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

Interventions

Conventional Non-Tunneled PICC catheterizationPROCEDURE

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 catheterizationPROCEDURE

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 catheterizationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: From catheterization to 90 days post-catheterization

Secondary Outcomes

One-Time Puncture Success Rate

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

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

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