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

Long Peripheral Intravenous Catheter Insertion Site and Catheter-related Complications in Antimicrobial Therapy: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Antimicrobial
• Intervention / Treatment: Device: insert catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of catheter-related complications	Catheter-related complications were assessed including thrombophlebitis, other phlebitis, catheter occlusion, bleeding, catheter-related infections, and weeping.	After insertion of catheter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After insertion of catheter
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.	After insertion of catheter.
Indwelling catheter duration	The Indwelling catheter duration refers to the number of days between the date of catheter placement and its removal.	After insertion of catheter

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital
• Investigators: Principal Investigator: Zhao Linfang, Sir Run Run Shaw Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Actual): December 25, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-2233-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No