Effects of Different PICC Catheterization Methods: A Multicenter Randomized Controlled Trial
25 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Geschat)
801
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Zeyin Hu
- Telefoonnummer: 86+15899954190
- E-mail: huzy@sysucc.org.cn
Studie Locaties
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Sun Yat-sen University Cancer Center
-
Contact:
- Jiasheng Huang
- Telefoonnummer: 86+17602023464
- E-mail: huangjs1@sysucc.org.cn
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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.
|
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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall Incidence of Catheter-Related Complications Within 90 Days Post-catheterization
Tijdsspanne: From catheterization to 90 days post-catheterization
|
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.
|
From catheterization to 90 days post-catheterization
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
One-Time Puncture Success Rate
Tijdsspanne: Day 1 During catheterization procedure
|
Proportion of patients in whom the first puncture successfully enters the vein and the guidewire is smoothly advanced.
|
Day 1 During catheterization procedure
|
|
Pain Intensity During Catheterization (NRS Score)
Tijdsspanne: Day 1 Immediately after catheterization procedure
|
Pain level assessed using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) immediately after catheterization.
|
Day 1 Immediately after catheterization procedure
|
|
Intraoperative Bleeding Volume
Tijdsspanne: Day 1 From start to end of catheterization procedure
|
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).
|
Day 1 From start to end of catheterization procedure
|
|
Catheterization Procedure Time
Tijdsspanne: Day 1 During catheterization procedure
|
Time from the first skin puncture to the moment the catheter is delivered to the predetermined length.
|
Day 1 During catheterization procedure
|
|
Unplanned Catheter Removal Rate
Tijdsspanne: From Day 1 catheterization to 90 days post-catheterization
|
Proportion of catheters removed prematurely due to complications (e.g., infection, thrombosis, dislodgement, occlusion) before the completion of treatment.
|
From Day 1 catheterization to 90 days post-catheterization
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
10 september 2026
Primaire voltooiing (Geschat)
30 mei 2027
Studie voltooiing (Geschat)
30 augustus 2027
Studieregistratiedata
Eerst ingediend
25 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
25 augustus 2026
Eerst geplaatst (Werkelijk)
28 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
28 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
25 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- Different PICC catheterization
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .