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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05242068
Other study ID # E.314064
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date January 5, 2020

Study information

Verified date February 2022
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date January 5, 2020
Est. primary completion date August 6, 2019
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Veinlite
Use of vein imaging device for visualization of veins during peripheral IV placement
Other:
Standard care
Patients received standard intravenous catheterization.

Locations

Country Name City State
Turkey Ege University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pain scores during peripheral intravenous catheterization 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. Immediately after IV placement
Secondary Catheter dwell time Intravenous catheter survival time during the treatment Up to 168 hours (1 week)
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