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CompletedNCT06455228Updated Apr 29, 2026

Long Peripheral Intravenous Catheter Insertion Site and Catheter-related Complications in Antimicrobial Therapy

An interventional study of insert catheter in Antimicrobial, sponsored by Sir Run Run Shaw Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Sir Run Run Shaw Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This study applies long PIVCs to patients undergoing antimicrobial therapy, and compares the effects of different placement sites, aiming to provide a reference basis for patients undergoing antimicrobial treatment to select the optimal placement site, thus reducing complications, prolonging catheter retention time, and alleviating the patient's pain.

Read the detailed description

This study investigates the use of long PIVCs in patients undergoing antimicrobial therapy, and compares the effects of different insertion sites. The aim is to provide evidence-based recommendations for the optimal placement site for long PIVCs in antimicrobial treatment, with the goals of reducing complications, prolonging catheter retention time, and alleviating patient discomfort.

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Conditions studied

  • Antimicrobial
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In context

Lead sponsor

Sir Run Run Shaw Hospital is the lead sponsor of 123 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ① estimated time of intravenous infusion ≥1 week; ② age: ≥18 years; ③ antimicrobial therapy was only used for treatment during hospitalization, with a pH value of 5-9 and osmotic pressure \< 900 mOsm/L; and ④ patients were conscious and able to communicate normally; ⑤ the catheter-to-vessel ratio is less than 45%.

Exclusion criteria

Exclusion Criteria:

  • ① a history of radiotherapy, thrombosis, and trauma at the catheterization site and ② plans to discharge with a catheter during the study duration.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    upper arm

    ①Evaluation: The puncture site was determined by senior nurses based on group assignment before placement. The depth and diameter of the pre-punctured vein were measured using ultrasound assessment, and the intima of the pre-punctured vein was examined without applying a tourniquet. ②Catheterization: A 3 Fr, 8 cm tip-opened long PIVC was used. Catheters were placed according to the designated sites for each group using ultrasound-guided and accelerated Seidinger techniques. After confirming catheter placement, needleless connectors and extension were attached, and the catheter was secured without tension using a sterile transparent dressing. ③Maintenance: Specialized nurses were trained to monitor and evaluate catheter function daily. Clinical nurses conducted routine maintenance until the study completion. Daily data were recorded and updated in computerized records.

    Device: insert catheter

  • Other
    forearm

    ①Evaluation: The puncture site was determined by senior nurses based on group assignment before placement. The depth and diameter of the pre-punctured vein were measured using ultrasound assessment, and the intima of the pre-punctured vein was examined without applying a tourniquet. ②Catheterization: A 3 Fr, 8 cm tip-opened long PIVC was used. Catheters were placed according to the designated sites for each group using ultrasound-guided and accelerated Seidinger techniques. After confirming catheter placement, needleless connectors and extension were attached, and the catheter was secured without tension using a sterile transparent dressing. ③Maintenance: Specialized nurses were trained to monitor and evaluate catheter function daily. Clinical nurses conducted routine maintenance until the study completion. Daily data were recorded and updated in computerized records.

    Device: insert catheter

Interventions

  • Deviceinsert catheter

    A fixed routine for pre-insertion cleaning and equipment was followed, including hand washing, placing the patient in a recumbent position, skin antisepsis, and preparation of the sterile field. Catheter insertion was performed by senior specialized nurses in the intravenous treatment room, which was a standardized setting for venipuncture.

06

What researchers measure

Primary outcomes

  1. Incidence of catheter-related complications

    Catheter-related complications were assessed including thrombophlebitis, other phlebitis, catheter occlusion, bleeding, catheter-related infections, and weeping.

    Time frame: After insertion of catheter

Secondary outcomes

  1. Puncture success rate with one-attempt

    The puncture success rate with one-attempt refers to the instance where the puncture needle successfully enters the target vein on the first attempt without needing to change the puncture site.

    Time frame: After insertion of catheter

  2. The procedure time

    The procedure time is defined as the duration from the start of skin disinfection to the stabilization of the catheter with dressing.

    Time frame: After insertion of catheter.

  3. Indwelling catheter duration

    The Indwelling catheter duration refers to the number of days between the date of catheter placement and its removal.

    Time frame: After insertion of catheter

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Study locations

1 site
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    Hangzhou, 310016, China
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References and documents

Publications

  • Zhao L, Jin X, Li X, Liu C, Wang J, Cao X, Zeng X, Zhuang Y. Differences in catheter-related complications to insertion site selection for long peripheral intravenous catheters in antimicrobial therapy: a randomized controlled trial. BMC Nurs. 2025 Feb 4;24(1):131. doi: 10.1186/s12912-025-02749-y. PubMed 39905387 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06455228
Lead sponsor
Sir Run Run Shaw Hospital
Responsible party
Sponsor
First posted
Jun 12, 2024
Start date
May 30, 2024
Primary completion
Dec 25, 2024
Completion
Dec 31, 2024
Last update
Apr 29, 2026

Study contacts

Zhao Linfang
principal investigator · Sir Run Run Shaw Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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