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OpenTrials
Completed

NCT Number: NCT05769452

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

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.

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Key information

Conditions

Catheter Complications Catheter Leakage

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

closed IV catheter system (BD Nexiva™)

Device

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.

Other names: BD Nexiva™

open IV catheter (BD Insyte™ Autoguard™)

Device

BD Instaflash™ needle technology improves initial entry success by confirming vascular access through the needle noch. It has flexible wings for secure cannula fixation.

Other names: BD Insyte™ Autoguard™

Primary outcomes

  1. catheter indwelling time

    Time frame: during the catheterization

    time between catheter insertion and removal

  2. success of catheter placement

    Time frame: at catheter insertion

    first IV attempt

Secondary outcomes

  1. development of catheter complications

    Time frame: during the catheterization

    infiltration

Sponsors and collaborators

Lead sponsor

Gülçin Özalp Gerçeker

Other

Registry information

Official study title

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

Acronym: nexiva

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2023
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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