Cancer Patients
Conditions
Keywords
Peripherally inserted central catheters ; tunneled; complications
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.
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).
Interventions
PROCEDUREConventional 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.
PROCEDUREOne-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.
PROCEDURETwo-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.
Sponsors
Sun Yat-sen University
Gansu Hospital of Sun Yat-sen University Cancer Center
Shenzhen People's Hospital
Zhongshan People's Hospital, Guangdong, China
First Affiliated Hospital of Jinan University
Haikou People's Hospital
The First Affiliated Hospital of Nanchang University
Jiangsu Cancer Institute & Hospital
Wuzhou Red Cross Hospital
Renmin Hospital of Wuhan University
Jieyang People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Incidence of Catheter-Related Complications Within 90 Days Post-catheterization | 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
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Bleeding Volume | 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). |
| Catheterization Procedure Time | Day 1 During catheterization procedure | Time from the first skin puncture to the moment the catheter is delivered to the predetermined length. |
| Unplanned Catheter Removal Rate | 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. |
| Pain Intensity During Catheterization (NRS Score) | 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. |
| One-Time Puncture Success Rate | Day 1 During catheterization procedure | Proportion of patients in whom the first puncture successfully enters the vein and the guidewire is smoothly advanced. |
Countries
China
Contacts
CONTACTZeyin Hu
Outcome results
None listed