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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05769452
Acronym
nexiva
Enrollment
214
Registered
2023-03-15
Start date
2022-04-01
Completion date
2022-11-30
Last updated
2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Complications, Catheter Leakage

Keywords

closed IV catheter system, pediatric hematology oncology, first IV attempt

Brief 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.

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.

Interventions

DEVICEclosed 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.

DEVICEopen 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.

Sponsors

Gülçin Özalp Gerçeker
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
catheter indwelling timeduring the catheterizationtime between catheter insertion and removal
success of catheter placementat catheter insertionfirst IV attempt

Secondary

MeasureTime frameDescription
development of catheter complicationsduring the catheterizationinfiltration

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026