Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children

NCT ID: NCT05242068

Last Updated: 2022-02-16

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

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-01-05

Brief Summary

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This study was conducted to investigate the use of Veinlite LED+ (TransLite, Sugar Land, Tex) to assist with PIC placement. The Veinlite uses LED (light-emitting diode) lights to enhance the visualization of veins by using orange and red color that are absorbed in venous blood.

The investigators' hypothesis for this study was that the vein imaging would reduce the complications related to catheter and the pain that the participants would feel.

Detailed Description

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Peripheral Intravenous Catheterization (PIC) introduces multiple risks and potential morbidities. Patients with PIC-associated complications have longer length of stay, higher clinical and economic burden, and greater risk of death than patients without. The most serious complications due to intravenous (IV) catheters are infiltration and extravasation.

The primary endpoint was to evaluate whether Veinlite LED+ would prevent catheter-related complications.

The secondary endpoint were;

1. to evaluate the efficacy of the vein imaging device on pediatric pain during intravenous catheterization
2. to evaluate the efficacy of the vein imaging device on catheter dwell time.

Conditions

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Catheterization Pain Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study was a prospective randomized controlled clinical study of children treated in a pediatric surgical ward who required PIC. The aim of the research was to evaluate whether the Veinlite would prevent catheter-related complications
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard care of group

Patients in standard care of group received traditional peripheral intravenous catheterization

Group Type OTHER

Standard care

Intervention Type OTHER

Patients received standard intravenous catheterization.

Veinlite group

Patients in veinlite group received peripheral intravenous catheterization with Veinlite

Group Type EXPERIMENTAL

Veinlite

Intervention Type DEVICE

Use of vein imaging device for visualization of veins during peripheral IV placement

Interventions

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Veinlite

Use of vein imaging device for visualization of veins during peripheral IV placement

Intervention Type DEVICE

Standard care

Patients received standard intravenous catheterization.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children aged between 5 and 18
* Children with DIVA (Difficult intravenous access score) score 4 or more
* That the child and the parent speak Turkish

Exclusion Criteria

* needing urgent treatment
* a critical health condition
* That the child or the parent has a communication problem
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Ayşe Kahraman

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ege University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E.314064

Identifier Type: -

Identifier Source: org_study_id

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