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Clinical Trials/NCT05242068
NCT05242068CompletedNot Applicable

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

Ege University1 site in 1 country139 target enrollmentStarted: December 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
139
Locations
1
Primary Endpoint
Reducing number of complications related with peripheral intravenous catheter

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
5 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Standard care of group

Other

Patients in standard care of group received traditional peripheral intravenous catheterization

Intervention: Standard care (Other)

Veinlite group

Experimental

Patients in veinlite group received peripheral intravenous catheterization with Veinlite

Intervention: Veinlite (Device)

Outcomes

Primary Outcomes

Reducing number of complications related with peripheral intravenous catheter

Time Frame: Duration of catheter dwell time (up to 168 hours)

Reducing number of complications related with peripheral intravenous catheter during treatment

Secondary Outcomes

  • Catheter dwell time(Up to 168 hours (1 week))
  • Pain scores during peripheral intravenous catheterization(Immediately after IV placement)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ayşe Kahraman

associate professor

Ege University

Study Sites (1)

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