跳至主要内容
临床试验/NCT02318940
NCT02318940已完成不适用

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.

University of Chile4 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2014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
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

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

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pietro Pietroboni Fuster

Medico Pediatra

University of Chile

研究点 (4)

Loading locations...

相似试验