Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children

Not Applicable

Completed

• Conditions: Catheterization; Pain; Complication
• Interventions: Device: Veinlite; Other: Standard care

• Registration Number: NCT05242068
• Lead Sponsor: Ege University

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 Timeline

• Study Start: 2018-12-01
• Primary Completion: 2019-08-06
• Study Completion: 2020-01-05
• Study First Submitted: 2022-01-26
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-05
• Last Update Submitted: 2022-02-05
• Study First Posted: 2022-02-16
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Veinlite group	Veinlite	Patients in veinlite group received peripheral intravenous catheterization with Veinlite
Standard care of group	Standard care	Patients in standard care of group received traditional peripheral intravenous catheterization

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Catheter dwell time	Up to 168 hours (1 week)	Intravenous catheter survival time during the treatment
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.

Trial Locations

Locations (1)

Ege University; 🇹🇷 İzmir, Turkey