Effects of Different PICC Catheterization Methods: A Multicenter Randomized Controlled Trial
25. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
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).
Studietype
Intervensjonell
Registrering (Antatt)
801
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Zeyin Hu
- Telefonnummer: 86+15899954190
- E-post: huzy@sysucc.org.cn
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina, 510000
- Sun Yat-sen University Cancer Center
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Ta kontakt med:
- Jiasheng Huang
- Telefonnummer: 86+17602023464
- E-post: huangjs1@sysucc.org.cn
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Incidence of Catheter-Related Complications Within 90 Days Post-catheterization
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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One-Time Puncture Success Rate
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Sponsor
Samarbeidspartnere
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
10. september 2026
Primær fullføring (Antatt)
30. mai 2027
Studiet fullført (Antatt)
30. august 2027
Datoer for studieregistrering
Først innsendt
25. august 2026
Først innsendt som oppfylte QC-kriteriene
25. august 2026
Først lagt ut (Faktiske)
28. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
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- Different PICC catheterization
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