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

NCT ID: NCT06455228

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-30

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antimicrobial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

insert catheter

Intervention Type DEVICE

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.

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.

Group Type OTHER

insert catheter

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sir Run Run Shaw Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhao Linfang

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Shaw Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhao Linfang

Role: CONTACT

13588819123

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhao Linfang

Role: primary

13588819123

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39905387 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-2233-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gentamicin Bladder Instillation on CAUTI
NCT06332040 RECRUITING PHASE4