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Completed

NCT Number: NCT05242068

Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children

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.

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Key information

Conditions

Catheterization Complication Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Turkey (Türkiye)

About this study

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;

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Veinlite

Device

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

Standard care

Other

Patients received standard intravenous catheterization.

Primary outcomes

  1. Reducing number of complications related with peripheral intravenous catheter

    Time frame: Duration of catheter dwell time (up to 168 hours)

    Reducing number of complications related with peripheral intravenous catheter during treatment

Secondary outcomes

  1. Pain scores during peripheral intravenous catheterization

    Time frame: Immediately after IV placement

    Pain scores by child, nurse, and parent. In this study, numerical rating score was used for determine pain level. The numeric rating scale is one of the most commonly used to obtain self-reports of pain intensity in school-age children, adolescents, and adults. The numerical rating scale (NRS) requires the child to rate her/his pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.

  2. Catheter dwell time

    Time frame: Up to 168 hours (1 week)

    Intravenous catheter survival time during the treatment

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children: Preliminary Results.

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 16, 2022
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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