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

Not Applicable

Completed

• Conditions: Catheter Complications; Catheter Leakage
• Interventions: Device: open IV catheter (BD Insyte™ Autoguard™); Device: closed IV catheter system (BD Nexiva™)

• Registration Number: NCT05769452
• Lead Sponsor: Gülçin Özalp Gerçeker

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.

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-30
• Status Verified: 2023-03
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-14
• Last Update Submitted: 2023-03-14
• Study First Posted: 2023-03-15
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BD Insyte™ Autoguard™	open IV catheter (BD Insyte™ Autoguard™)	The control group received an open IV catheter called BD Insyte™ Autoguard™.
BD Nexiva™	closed IV catheter system (BD Nexiva™)	The intervention group was given a closed IV catheter system called BD Nexiva™.

Primary Outcome Measures

Name	Time	Method
catheter indwelling time	during the catheterization	time between catheter insertion and removal
success of catheter placement	at catheter insertion	first IV attempt

Secondary Outcome Measures

Name	Time	Method
development of catheter complications	during the catheterization	infiltration

Trial Locations

Locations (1)

Gülçin Özalp Gerçeker; 🇹🇷 İzmir, Turkey