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

March 14, 2023 updated by: Gülçin Özalp Gerçeker

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35100
        • Gülçin Özalp Gerçeker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BD Nexiva™
The intervention group was given a closed IV catheter system called BD Nexiva™.
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.
Other Names:
  • BD Nexiva™
Experimental: BD Insyte™ Autoguard™
The control group received an open IV catheter called BD Insyte™ Autoguard™.
Device: 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.
Other Names:
  • BD Insyte™ Autoguard™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
catheter indwelling time
Time Frame: during the catheterization
time between catheter insertion and removal
during the catheterization
success of catheter placement
Time Frame: at catheter insertion
first IV attempt
at catheter insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
development of catheter complications
Time Frame: during the catheterization
infiltration
during the catheterization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gülçin Özalp Gerçeker

Investigators

  • Principal Investigator: Nur Olgun, MD, Dokuz Eylül University
  • Principal Investigator: Hale Ören, MD, Dokuz Eylül University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

November 15, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DEU PHO nexiva

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Catheter Complications

Clinical Trials on closed IV catheter system (BD Nexiva™)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe