Comparison of Effectiveness and Safety of Two Methods for Installing Femoral Central Venous Catheters in Pediatric Intensive Care Units : Anatomical Method vs Ultrasound in Real Time.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 4
- 主要终点
- Installation on the First Try
研究概览
简要总结
The purpose of this study is to compare the effectiveness and safety of the installation of femoral central venous catheter (CVC) ultrasound-guided real-time 2D versus the landmark method
详细描述
STUDY DESIGN Multicenter prospective randomized study in pediatric intensive care units of the Roberto del Rio's hospital and Exequiel González Cortés' hospital. Patients from entering the study between the months of January/2015 to December/2015, after signing informed by their parents or legal guardian consent, this will be implemented by the resident
PATIENTS Previous studies report an average success rate of 50% on the first attempt in the anatomical method, both children and adults. Sample size is determined to improve on a 30% success rate using the ultrasound method. For a power of 80% in relation to success at the first attempt and with a confidence level of 95%, a total of 50 patients per branch is determined.
Method of randomization Using computer program the patient leaving 50 patients in the group with the anatomical method, and 50 patients in the ultrasound method are randomized .
OPERATOR Both installation landmark and ultrasound guidance will be performed by 3 or 4 team doctors resident in each center , who count on ≥ 3 years of experience in ICU and training in ultrasound-guided access .
DEFINITIONS
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
- 1 Week 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Need for central venous access
排除标准
- •More than 15 years.
- •Local infection at the puncture site
- •Anatomical and / or functional vascular alteration known
结局指标
主要结局
Installation on the First Try
时间窗: intraoperative, an average of 1 hour
Percentage of Participants with successful installation on the first transcutaneous passage of the glass needle
次要结局
- Successful Installation(intraoperative, an average of 1 hour)
- Number of Attempts(intraoperative, an average of 1 hour)
- Arterial Puncture(intraoperative, an average of 1 hour)
研究者
Pietro Pietroboni Fuster
Medico Pediatra
University of Chile
