Vascular Ultrasound During the Use of Peripheral Intravenous Catheters in Children: A Clinical, Randomized and Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 335
- 试验地点
- 2
- 主要终点
- Venous access obtainment occurred in the two studied groups, with marginally significant statistical difference. The success in the first attempt of puncture was statistically similar.
研究概览
简要总结
This research, aimed to verify whether the use of vascular ultrasonography (VUS) could lead to better results in the peripheral venous access implementation in children.
Objectives: To compare, regardless of the number of venous puncture attempts, peripheral venous access obtained in children, according to VUS use or traditional method for peripheral intravenous catheter (PIC) insertion; assertiveness in the use of PIC in children, defined as success in the first attempt of puncture and PIC withdrawal according to release of treatment, related to VUS or traditional method and to describe the influence of VUS on PIC dwell time and development of local complications related to the use of intravenous therapy in children.
详细描述
Clinical, randomized and controlled trial, conducted in a pediatric surgery ward of a university hospital in São Paulo. Data collection occurred from February 26th, 2007 to July 07th, 2008, after ethical merits of research approval. The sample comprised 382 venous puncture randomly allocated in the experimental group (EG), venous puncture guided by VUS, or in the control group (CG), traditional method of venous puncture. Variables related to children, intravenous therapy and professional characterization were collected. The dependent variables included the obtainment of peripheral venous access, the assertiveness, the catheter dwell time and the occurrence of local complications. For the statistical analysis were applied the Pearson Chi-square, Fisher's Exact, Generalization of Fisher's exact, Mann-Whitney, Likelihood Ratio and Prevalence Ratio (significance level of 5%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children submitted to intravenous therapy
排除标准
- 未提供
结局指标
主要结局
Venous access obtainment occurred in the two studied groups, with marginally significant statistical difference. The success in the first attempt of puncture was statistically similar.
时间窗: 1 year and 5 months
次要结局
- The median of catheters dwell time was similar in the control group and experimental group. Infiltration had a different distribution between groups, been more frequent in the Experimental group.(1 year and 5 months)