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

NCT05769452 | Completed FDA Device

• 1 other identifier: DEU PHO nexiva
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter Complications; Catheter Leakage

Keywords

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

Outcome Measures

Primary Outcomes (2)

• catheter indwelling time

  time between catheter insertion and removal

  during the catheterization

• success of catheter placement

  first IV attempt

  at catheter insertion

Secondary Outcomes (1)

• development of catheter complications

  during the catheterization

Study Arms (2)

BD Nexiva™

EXPERIMENTAL

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

Device: closed IV catheter system (BD Nexiva™)

BD Insyte™ Autoguard™

EXPERIMENTAL

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

Device: open IV catheter (BD Insyte™ Autoguard™)

Interventions

closed IV catheter system (BD Nexiva™) 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.

Also known as: BD Nexiva™

BD Nexiva™

open IV catheter (BD Insyte™ Autoguard™) 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.

Also known as: BD Insyte™ Autoguard™

BD Insyte™ Autoguard™

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• port or central venous catheter in the pediatric patient

Sponsors & Collaborators

• Gülçin Özalp Gerçeker: lead

Study Sites (1)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 37879193 DERIVED

Study Officials

• Nur Olgun, MD

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• Hale Ören, MD

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: pHD, Assoc. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: April 1, 2022
• Primary Completion: November 15, 2022
• Study Completion: November 30, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

TU (1)