Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children

Sponsor

Ege University (Other)

Overall Status

Completed

CT.gov ID

NCT05242068

Collaborator

(none)

139

Enrollment

Location

Arms

13.1

Actual Duration (Months)

10.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Catheterization Pain Complication	Device: Veinlite Other: Standard care	N/A

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;

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

139 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 complicationsThis 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

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2018

Actual Primary Completion Date :

Aug 6, 2019

Actual Study Completion Date :

Jan 5, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Reducing number of complications related with peripheral intravenous catheter [Duration of catheter dwell time (up to 168 hours)]
Reducing number of complications related with peripheral intravenous catheter during treatment

Secondary Outcome Measures

Pain scores during peripheral intravenous catheterization [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.
Catheter dwell time [Up to 168 hours (1 week)]
Intravenous catheter survival time during the treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ege University	İzmir		Turkey

Sponsors and Collaborators

Ege University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayşe Kahraman, associate professor, Ege University

ClinicalTrials.gov Identifier:

NCT05242068

Other Study ID Numbers:

E.314064

First Posted:

Feb 16, 2022

Last Update Posted:

Feb 16, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ayşe Kahraman, associate professor, Ege University

pain

children

vein imaging device

intravenous complications

Study Results

No Results Posted as of Feb 16, 2022