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NCT07791719
Effects of Different PICC Catheterization Methods: A Multicenter Randomized Controlled Trial
Conditions: Cancer Patients
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 801
Sponsor: Sun Yat-sen University
Location: Sun Yat-sen University Cancer Center Guangzhou Guangdong
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07791719). StuddyBuddy aggregates publicly available trial information.