Clinical trial · Interventional
Effects of Different PICC Catheterization Methods: A Multicenter Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Non-Tunneled PICC catheterization | Procedure | — | UNRESOLVED |
| One-Needle Tunneled PICC catheterization | Procedure | — | UNRESOLVED |
| Two-Needle Tunneled PICC catheterization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Conventional Non-Tunneled PICC catheterization
- description
- 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.
- interventionNames
- Procedure: Conventional Non-Tunneled PICC catheterization
- type
- EXPERIMENTAL
- label
- One-Needle Tunneled PICC catheterization
- description
- 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.
- interventionNames
- Procedure: One-Needle Tunneled PICC catheterization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available