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临床试验/NCT03277092
NCT03277092已完成不适用

Impact of Near Infrared Light in Paediatric Blood Drawing Centre on Rate of First Attempt Success and Time of Procedure

IRCCS Burlo Garofolo2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2017年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
115
试验地点
2
主要终点
Time to perform the procedure

研究概览

简要总结

Reaching a peripheral venous access or making a blood sample in a scared infant or toddler can be challenging even for experienced nurses o pediatricians. Up to 60% of children report pain and distress during venipuncture and multiple attempts can result in more difficult physical and emotional conditions for subsequent insertions so that the procedure should be performed with the less number of punctures as possible. In about one third of children, more than one attempt is required to achieve peripheral intravenous cannulation. In the last years, specific tools have been developed to enhance the success in venipuncture or incannulation. Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site. According to previous studies, NIR had shown a trend in reduction of time employed for a blood sample, in children younger of 6 yr.

The aim of this trial is to investigate if the use of the VeinViewer® in a pediatric blood drawing center could decrease time spent to perform the procedure and improve the rate of first attempt success.

研究设计

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

入排标准

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

入选标准

  • subjects accessing the outpatient blood-drawing service

排除标准

  • application of topical anaesthetic cream

研究组 & 干预措施

VeinViewer® group

Experimental

Use of near infrared light to perform blood draw (VeinViewer®)

干预措施: VeinViewer® (Device)

Usual care group

Active Comparator

Blood drawing performed traditionally

干预措施: Usual care (Procedure)

结局指标

主要结局

Time to perform the procedure

时间窗: Intraprocedural

In seconds, from the placement of the tourniquet until the blood flows in the needle

次要结局

  • Success at first attempt(Intraprocedural)

研究者

发起方
IRCCS Burlo Garofolo
申办方类型
Other
责任方
Sponsor

研究点 (2)

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