Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05242068
• Other study ID #: E.314064
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Catheterization
• Complication
• Pain

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)