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临床试验/NCT05242068
NCT05242068已完成不适用

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

Ege University1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
1
主要终点
Reducing number of complications related with peripheral intravenous catheter

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • needing urgent treatment
  • a critical health condition
  • That the child or the parent has a communication problem

结局指标

主要结局

Reducing number of complications related with peripheral intravenous catheter

时间窗: Duration of catheter dwell time (up to 168 hours)

Reducing number of complications related with peripheral intravenous catheter during treatment

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayşe Kahraman

associate professor

Ege University

研究点 (1)

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