Peripheral Intravenous Catheter Bundle (deu-acil-bd)

November 22, 2025 updated by: Gülçin Özalp Gerçeker

The Effect of Peripheral Intravenous Catheter Bundle on Catheter Insertion Success, Complication Development, and Procedure-Related Pain in Patients Presenting to the Pediatric Emergency Department

The study was designed to investigate the effects of a PIVC Bundle, which includes a vein visualization device and a vial (BD Neoflon™ Pro catheter), on catheter placement success, complications, procedure-related pain, and catheter length of stay in children aged 1-6 years who are scheduled for peripheral intravenous catheter (PIVC) insertion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study sample included four groups: (1) vein visualization device (VGC) and Vialon Catheter Group, (2) VGC and Standard/Teflon Catheter Group, (3) Vialon Catheter Group, (4) Standard/Teflon Catheter Group/Control Group. Data were collected using the Socio-Demographic Data Collection Form, the Forced Intravenous Intervention Score, the PIVC Site Follow-up Form, the Infiltration Scale, the Extravasation Scale, the Phlebitis Scale, and the FLACC Pain Diagnosis Scale.

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • must be between 1 and 6 years old.
  • must be inserted PIC

Exclusion Criteria:

  • must be shock or severe dehydration, unconsciousness.
  • had a central catheter.
  • must be inserted at the lower extremities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vein Imaging Device and Vialon Catheter Group
Using a PIVC bundle,Vein Imaging Device, and Vialon catheters
Device: Vein Imaging Device
Vein Imaging Device before PIVC insertion
Device: Vialon catheters
Vialon catheter use for PIVC insertion
Experimental: Vein Imaging Device and Standard/Teflon Catheter Group
Using a PIVC bundle,Vein Imaging Device, and Teflon catheters
Device: Vein Imaging Device
Vein Imaging Device before PIVC insertion
Experimental: Vialon Catheter Group
Using a PIVC bundle and Vialon catheters
Device: Vialon catheters
Vialon catheter use for PIVC insertion
No Intervention: Standard/Teflon Catheter Group
Using a PIVC bundle and Teflon catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PIVC insertion related pain score
Time Frame: FLACC score evaluated 3 minutes after the PIVC insertion
The FLACC (Face, Legs, Activity, Cry, Consolability) score related to the PIVC insertion. The scale is scored in a range of 0-10, with 0 representing no pain. Assessment of score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
FLACC score evaluated 3 minutes after the PIVC insertion
PIVC indwelling time
Time Frame: immediately after the PIC intervention
PIVC stay time
immediately after the PIC intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gülçin Özalp Gerçeker

Investigators

  • Principal Investigator: Gulcin ÖZALP GERÇEKER, Dokuz Eylul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

February 1, 2025

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

November 22, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 22, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • deu-560

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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