Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children

NCT05242068 | Completed

• 1 other identifier: E.314064
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catheterization; Pain; Complication

Keywords

pain; children; vein imaging device; intravenous complications

Outcome Measures

Primary Outcomes (1)

• Reducing number of complications related with peripheral intravenous catheter

  Reducing number of complications related with peripheral intravenous catheter during treatment

  Duration of catheter dwell time (up to 168 hours)

Secondary Outcomes (2)

• Pain scores during peripheral intravenous catheterization

  Immediately after IV placement

• Catheter dwell time

  Up to 168 hours (1 week)

Study Arms (2)

Standard care of group

OTHER

Patients in standard care of group received traditional peripheral intravenous catheterization

Other: Standard care

Veinlite group

EXPERIMENTAL

Patients in veinlite group received peripheral intravenous catheterization with Veinlite

Device: Veinlite

Interventions

Veinlite DEVICE

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

Veinlite group

Standard care OTHER

Patients received standard intravenous catheterization.

Standard care of group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Gender Eligibility Details: Children in both the Standard care of group and Veinlite group were to be stratified into three age groups: 5 to 9, 10 to 14 and 15 to 18
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• needing urgent treatment
• a critical health condition
• That the child or the parent has a communication problem

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: 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

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 16, 2022
• Study Start: December 1, 2018
• Primary Completion: August 6, 2019
• Study Completion: January 5, 2020
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)