Peripheral Veins Cannulation in Children Using Veinsite: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- success of peripheral vein access positioning
研究概览
简要总结
multicenter, prospective and cohort study to evaluate infrared technology for identifying and and indwelling peripheral veins in 0 up to 4 years old children.
详细描述
AIM OF THE STUDY The primary objective of this study is to determine the success rate at first attempt of peripheral veins cannulation in small children (<5yrs) and infants (<1yr) of Veinsite compared with traditional palpation method performed by skilled operators.
The secondary objective of this study is to determine the time to cannulation using the two techniques, the difference in visualized veins using the Veinsite or the direct visualization and palpation of the patients' skin, cannula indwelling time and complications related to the procedure.
DESIGN Prospective randomized controlled study
Population
It is expected to recruit 60 pediatric patients undergoing peripheral vein cannulation with known difficulties according the difficult venous access score (DIVA) (6) in the following centers:
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 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female children from 1 month to 5 years Of age
- •American Society of Anesthesiologists Classification (ASA) I: without systemic disease
- •American Society of Anesthesiologists Classification (ASA) II: moderate systemic disease
- •American Society of Anesthesiologists Classification (ASA) III: severe systemic disease that limits normal activity, without invalidity.
- •Scheduled for any indication of peripheral venous line placement
- •Admission to an Intensive Care Unit, Neurosurgery ward or pediatric ward of one of the hospitals included
- •Children whose parents (or legal tutors) have given their informed written consent
排除标准
- •Any contraindication for peripheral line placement
- •Children whose parents (or legal tutors) denied their own consensus
结局指标
主要结局
success of peripheral vein access positioning
时间窗: 2 year
to determine the success rate at first attempt of peripheral veins cannulation in small children (\<5yrs) and infants (\<1yr) of Veinsite compared with traditional palpation method performed by skilled operators.
次要结局
- impact of DIVA score(difficult vein access score) on time of success number of participants with treatment-related peripheral vein cannulation failure(2 year)
研究者
Emanuele Rossetti
MD
Bambino Gesù Hospital and Research Institute