Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Complication; Catheterization
• Intervention / Treatment: Other: Standard care; Device: Veinlite

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard care of group; Patients in standard care of group received traditional peripheral intravenous catheterization	Other: Standard care; Patients received standard intravenous catheterization.
Experimental: Veinlite group; Patients in veinlite group received peripheral intravenous catheterization with Veinlite	Device: Veinlite; Use of vein imaging device for visualization of veins during peripheral IV placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Catheter dwell time	Intravenous catheter survival time during the treatment	Up to 168 hours (1 week)

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): August 6, 2019
• Study Completion (Actual): January 5, 2020

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 5, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 5, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: pain; children; vein imaging device; intravenous complications
• Other Study ID Numbers: E.314064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No