Effects of Different PICC Catheterization Methods: A Multicenter Randomized Controlled Trial
2026年8月25日 更新者：Zeyin Hu、Sun Yat-sen University
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.
研究概览
地位
尚未招聘
条件
详细说明
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).
研究类型
介入性
注册 (估计的)
801
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zeyin Hu
- 电话号码：86+15899954190
- 邮箱：huzy@sysucc.org.cn
学习地点
-
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Guangdong
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Guangzhou、Guangdong、中国、510000
- Sun Yat-sen University Cancer Center
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接触：
- Jiasheng Huang
- 电话号码：86+17602023464
- 邮箱：huangjs1@sysucc.org.cn
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
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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.
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|
实验性的：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.
|
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.
|
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实验性的：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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Incidence of Catheter-Related Complications Within 90 Days Post-catheterization
大体时间：From catheterization to 90 days post-catheterization
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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.
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From catheterization to 90 days post-catheterization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
One-Time Puncture Success Rate
大体时间：Day 1 During catheterization procedure
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Proportion of patients in whom the first puncture successfully enters the vein and the guidewire is smoothly advanced.
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Day 1 During catheterization procedure
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Pain Intensity During Catheterization (NRS Score)
大体时间：Day 1 Immediately after catheterization procedure
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Pain level assessed using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) immediately after catheterization.
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Day 1 Immediately after catheterization procedure
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Intraoperative Bleeding Volume
大体时间：Day 1 From start to end of catheterization procedure
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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).
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Day 1 From start to end of catheterization procedure
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Catheterization Procedure Time
大体时间：Day 1 During catheterization procedure
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Time from the first skin puncture to the moment the catheter is delivered to the predetermined length.
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Day 1 During catheterization procedure
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Unplanned Catheter Removal Rate
大体时间：From Day 1 catheterization to 90 days post-catheterization
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Proportion of catheters removed prematurely due to complications (e.g., infection, thrombosis, dislodgement, occlusion) before the completion of treatment.
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From Day 1 catheterization to 90 days post-catheterization
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月10日
初级完成 (估计的)
2027年5月30日
研究完成 (估计的)
2027年8月30日
研究注册日期
首次提交
2026年8月25日
首先提交符合 QC 标准的
2026年8月25日
首次发布 (实际的)
2026年8月28日
研究记录更新
最后更新发布 (实际的)
2026年8月28日
上次提交的符合 QC 标准的更新
2026年8月25日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- Different PICC catheterization
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
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