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

Study Overview
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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.

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

Conditions
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Catheter Complications, Catheter Leakage

Intervention / Treatment
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* Device: closed IV catheter system (BD Nexiva™)
* Device: open IV catheter (BD Insyte™ Autoguard™)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BD Nexiva™<br>The intervention group was given a closed IV catheter system called BD Nexiva™. | Device: closed IV catheter system (BD Nexiva™)<br>* 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.<br>* Other names: BD Nexiva™;|
| Experimental: BD Insyte™ Autoguard™<br>The control group received an open IV catheter called BD Insyte™ Autoguard™. | Device: open IV catheter (BD Insyte™ Autoguard™)<br>* BD Instaflash™ needle technology improves initial entry success by confirming vascular access through the needle noch. It has flexible wings for secure cannula fixation.<br>* Other names: BD Insyte™ Autoguard™;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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closed IV catheter system, pediatric hematology oncology, first IV attempt