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NCT05769452 Clinical Trial

Closed Intravenous Catheter System on Catheter Success, Length of Stay and Complications

Catheter Complications Clinical Trial

— nexiva  

Official title:
Effect of Closed Intravenous Catheter System on Catheter Success, Length of Stay and Complications in Pediatric Hematology and Oncology Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05769452
Other study ID # DEU PHO nexiva
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date November 30, 2022

Study information
Verified date March 2023
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Peripheral intravenous catheters (PIVCs) can be used frequently in pediatric hematology oncology patients. There are different types of PIVCs as open and closed. There are studies on adults using the closed IV catheter system, which is a type of PICK. However, no study was found in the literature in which the closed IV catheter system was used in the pediatric population.

Description:

The primary purpose of this research is; to evaluate the effect of two different catheter systems (closed IV catheter system: BD Nexiva™/ peripheral open IV catheter: BD Insyte™ Autoguard™) on catheter stay in pediatric hematology and oncology patients aged 1-12 years. The secondary aim of the research is; to evaluate the effect of two different catheter systems on the success of catheter placement and the development of complications in the first attempt in pediatric hematology and oncology patients.

Recruitment information / eligibility
Status Completed
Enrollment 214
Est. completion date November 30, 2022
Est. primary completion date November 15, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 12 Years
Eligibility Inclusion Criteria: - Age range of pediatric patients is between 1-12 - Obtaining an informed consent form from the child patient and parent - Child patient receiving intravenous therapy Exclusion Criteria: - port or central venous catheter in the pediatric patient

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• closed IV catheter system (BD Nexiva™)
There is a high-pressure extension set and a Q-syte split septum needle-free intervention device at the tip of the catheter. It creates a closed integrated system with this apparatus, reducing the risk of catheter-related bloodstream infection.
• open IV catheter (BD Insyte™ Autoguard™)
BD Instaflash™ needle technology improves initial entry success by confirming vascular access through the needle noch. It has flexible wings for secure cannula fixation.

Locations
Country Name City State
Turkey Gülçin Özalp Gerçeker Izmir

Sponsors (1)
Lead Sponsor Collaborator
Gülçin Özalp Gerçeker

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary catheter indwelling time time between catheter insertion and removal during the catheterization
Primary success of catheter placement first IV attempt at catheter insertion
Secondary development of catheter complications infiltration during the catheterization
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