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

NCT ID: NCT05769452

Last Updated: 2023-03-15

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Catheter Complications Catheter Leakage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In this study, the intervention group was given a closed IV catheter system called BD Nexiva™; the control group received an open IV catheter called BD Insyte™ Autoguard™. Within the scope of the study, "Peripheral IV Catheter Care Bundle Approach" was applied to all patients.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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BD Nexiva™

The intervention group was given a closed IV catheter system called BD Nexiva™.

Group Type EXPERIMENTAL

closed IV catheter system (BD Nexiva™)

Intervention Type 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.

BD Insyte™ Autoguard™

The control group received an open IV catheter called BD Insyte™ Autoguard™.

Group Type EXPERIMENTAL

open IV catheter (BD Insyte™ Autoguard™)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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BD Nexiva™ BD Insyte™ Autoguard™

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gülçin Özalp Gerçeker

OTHER

Sponsor Role lead

Responsible Party

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Gülçin Özalp Gerçeker

pHD, Assoc. Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nur Olgun, MD

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Hale Ören, MD

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

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Gülçin Özalp Gerçeker

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Ozalp Gerceker G, Yildirim BG, Onal A, Oren H, Olgun HN, Bektas M. The effect of the closed intravenous catheter system on first insertion success, indwelling time, and complications in pediatric hematology and oncology patients: A randomized controlled study. Eur J Oncol Nurs. 2023 Dec;67:102430. doi: 10.1016/j.ejon.2023.102430. Epub 2023 Oct 7.

Reference Type DERIVED
PMID: 37879193 (View on PubMed)

Other Identifiers

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DEU PHO nexiva

Identifier Type: -

Identifier Source: org_study_id

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