Peripheral Intravenous Catheter Bundle

NCT ID: NCT07249255

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pediatric Catheter Complications Catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vein Imaging Device and Vialon Catheter Group

Using a PIVC bundle,Vein Imaging Device, and Vialon catheters

Group Type EXPERIMENTAL

Vein Imaging Device

Intervention Type DEVICE

Vein Imaging Device before PIVC insertion

Vialon catheters

Intervention Type DEVICE

Vialon catheter use for PIVC insertion

Vein Imaging Device and Standard/Teflon Catheter Group

Using a PIVC bundle,Vein Imaging Device, and Teflon catheters

Group Type EXPERIMENTAL

Vein Imaging Device

Intervention Type DEVICE

Vein Imaging Device before PIVC insertion

Vialon Catheter Group

Using a PIVC bundle and Vialon catheters

Group Type EXPERIMENTAL

Vialon catheters

Intervention Type DEVICE

Vialon catheter use for PIVC insertion

Standard/Teflon Catheter Group

Using a PIVC bundle and Teflon catheters

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vein Imaging Device

Vein Imaging Device before PIVC insertion

Intervention Type DEVICE

Vialon catheters

Vialon catheter use for PIVC insertion

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gülçin Özalp Gerçeker

OTHER

Sponsor Role lead

Responsible Party

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Gülçin Özalp Gerçeker

Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gulcin ÖZALP GERÇEKER

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

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Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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deu-560

Identifier Type: -

Identifier Source: org_study_id

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