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Effects of Different Tunnel Methods in PICC Catheterization

18. maj 2026 opdateret af: Zeyin Hu, Sun Yat-sen University

Effects of Different Tunnel Methods in PICC Catheterization: A Randomized Controlled Trial

This prospective randomized controlled trial compares the effectiveness and safety of one-needle and two-needle tunneling techniques for peripherally inserted central catheter (PICC) placement, aiming to identify the optimal tunneling method to reduce catheter-related complications.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

284

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Zeyin Hu
Telefonnummer: 15899954190
E-mail: huzy@sysucc.org.cn

Studiesteder

Kina
- Guangdong
  - Guangzhou, Guangdong, Kina, 510000
    - Rekruttering
    - Sun Yat-sen University Cancer Center
    - Kontakt:
      
      Zeyin Hu
      
      Telefonnummer: 15899954190
      
      E-mail: huzy@sysucc.org.cn

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

Aged between 18 and 75 years old;
Educational level of primary school or above, with basic listening, speaking, reading and writing abilities, and capable of completing the questionnaire independently;
Receiving tunneled PICC catheterization for the first time, with 4Fr single-lumen solo PICC catheter indwelling;
Able to attend regular PICC maintenance at our hospital as scheduled after catheterization;
Voluntarily participate in this study and sign the informed consent form for this study as well as the informed consent form for PICC catheterization.

Exclusion Criteria:

Patients with coagulation dysfunction (INR > 1.5 / PLT < 50×10⁹/L);
Pregnant or lactating women;
Patients with BMI < 18.5 kg/m²;
Patients receiving PICC catheterization via lower extremity veins;
Patients with known or suspected allergy to components of PICC catheters.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Andet
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Tredobbelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Aktiv komparator: cancer patients who undergo PICC placement using two-needle tunnel technique Two-needle tunnel PICC procedure: Local anesthesia at puncture and catheter exit sites; Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle; Skin dilation at both puncture and exit sites; 4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution; Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site; Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal; Vascular sheath peeled off, catheter adjusted to proper position; Catheter tip position confirmed; Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured.	Andet: two-needle tunnel technique Two-needle tunnel PICC procedure: Local anesthesia at puncture and catheter exit sites; Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle; Skin dilation at both puncture and exit sites; 4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution; Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site; Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal; Vascular sheath peeled off, catheter adjusted to proper position; Catheter tip position confirmed; Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured.
Eksperimentel: cancer patients who undergo PICC placement using one-needle tunnel technique Ultrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation: Local anesthesia is administered at the puncture site，the puncture needle travels 4 cm through the subcutaneous tissue before entering the blood vessel; The guide wire is inserted along the puncture needle; skin dilation; The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath; The catheter tip position is confirmed, and the catheter is secured.	Andet: One-needle tunnel technique Local anesthesia is administered at the puncture site，Ultrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation，the puncture needle travels 4 cm through the subcutaneous tissue before entering the blood vessel; The guide wire is inserted along the puncture needle; skin dilation; The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath; The catheter tip position is confirmed, and the catheter is secured.

Deltagergruppe / Arm

Intervention / Behandling

Aktiv komparator: cancer patients who undergo PICC placement using two-needle tunnel technique

Two-needle tunnel PICC procedure:

Local anesthesia at puncture and catheter exit sites;
Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle;
Skin dilation at both puncture and exit sites;
4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution;
Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site;
Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal;
Vascular sheath peeled off, catheter adjusted to proper position;
Catheter tip position confirmed;
Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured.

Andet: two-needle tunnel technique

Two-needle tunnel PICC procedure:

Local anesthesia at puncture and catheter exit sites;
Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle;
Skin dilation at both puncture and exit sites;
4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution;
Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site;
Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal;
Vascular sheath peeled off, catheter adjusted to proper position;
Catheter tip position confirmed;
Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured.

Eksperimentel: cancer patients who undergo PICC placement using one-needle tunnel technique

Ultrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation:

Local anesthesia is administered at the puncture site，the puncture needle travels 4 cm through the subcutaneous tissue before entering the blood vessel;
The guide wire is inserted along the puncture needle;
skin dilation;
The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath;
The catheter tip position is confirmed, and the catheter is secured.

Andet: One-needle tunnel technique

Local anesthesia is administered at the puncture site，Ultrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation，the puncture needle travels 4 cm through the subcutaneous tissue before entering the blood vessel;
The guide wire is inserted along the puncture needle;
skin dilation;
The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath;
The catheter tip position is confirmed, and the catheter is secured.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
overall PICC-related complications after catheter placement Tidsramme: 4 weeks after PICC placement	these complications include catheter exit site oozing, contact dermatitis, venous thrombosis, infection, catheter displacement or dislodgement, mechanical phlebitis, catheter occlusion, and catheter fracture or damage.	4 weeks after PICC placement

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
first-puncture success rate of PICC catheterization Tidsramme: day 1 during PICC catheterization		day 1 during PICC catheterization
Bleeding during PICC placement Tidsramme: Day 1 during PICC placement		Day 1 during PICC placement
unplanned catheter removal rate of PICC Tidsramme: 4 weeks after PICC placement		4 weeks after PICC placement
pain score Tidsramme: Day 1 during PICC placement	Evaluated by Numerical Rating Scale , a self-report tool where individuals rate their pain intensity from 0 (no pain) to 10 (worst possible pain)，with higher scores indicating more severe pain.	Day 1 during PICC placement

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sun Yat-sen University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2026

Primær færdiggørelse (Anslået)

30. juni 2026

Studieafslutning (Anslået)

30. juli 2026

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

13. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

B2026-068-01

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Effects of Different Tunnel Methods in PICC Catheterization