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Effects of Different Tunnel Methods in PICC Catheterization

18 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

284

Fas

Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Zeyin Hu
Telefonnummer: 15899954190
E-post: huzy@sysucc.org.cn

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Övrig
Tilldelning: Randomiserad
Interventionsmodell: Parallellt uppdrag
Maskning: Trippel

Antal vapen

Vapen och interventioner

Deltagargrupp / 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.	Övrig: 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.
Experimentell: 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.	Övrig: 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.

Deltagargrupp / 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.

Övrig: 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.

Experimentell: 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.

Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
overall PICC-related complications after catheter placement Tidsram: 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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
first-puncture success rate of PICC catheterization Tidsram: day 1 during PICC catheterization		day 1 during PICC catheterization
Bleeding during PICC placement Tidsram: Day 1 during PICC placement		Day 1 during PICC placement
unplanned catheter removal rate of PICC Tidsram: 4 weeks after PICC placement		4 weeks after PICC placement
pain score Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Sun Yat-sen University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 april 2026

Primärt slutförande (Beräknad)

30 juni 2026

Avslutad studie (Beräknad)

30 juli 2026

Studieregistreringsdatum

Först inskickad

13 maj 2026

Först inskickad som uppfyllde QC-kriterierna

13 maj 2026

Första postat (Faktisk)

19 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

B2026-068-01

Plan för individuella deltagardata (IPD)

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Effects of Different Tunnel Methods in PICC Catheterization