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临床试验/NCT04211116
NCT04211116已完成不适用

Central Venous Catheters in Pediatric Anesthesia and Intensive Care: Prospective Observational Trial

Brno University Hospital1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2020年3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
107
试验地点
1
主要终点
Overall success and first attempt success rate

研究概览

简要总结

Securing the intravenous line is one of the fundamental interventions in paediatric anaesthesia and intensive care. Central venous catheters (CVC) are indicated for long-term stay in intensive care unit (ICU), in case of circulatory instability and the need for vasopressor therapy, for hypertonic solutions administration and parenteral nutrition. The dominant method of CVC insertions is the Seldingers´ method (over the wire) and ultrasound real-time navigation in recommended. Ultrasound-guided (USG) CVC insertion however requires experience personnel and relevant training.This could be the main reason, that CVC the real-time ultrasound navigation is still not adequately implemented into the clinical practice.

详细描述

After Ethics committee approval, patients indicated for CVC insertions will be included. Based on the observational design of the trial, the method of insertion (Real-time ultrasound navigation versus anatomical-based CVC insertion) will be based on operators´ decision.The indication for CVC insertion, primary planned site of insertion, USG implementation, site of actual CVC cannulation and associated complications will be recorded. The primary aim of the study was to compare the effectivity of Real-time ultrasound navigation versus anatomical-based CVC insertion in paediatric patients and the 1st percutaneous puncture success rate. The secondary aims will be the incidence of associated complications and the time form first percutaneous puncture, to definitely securing the CVC in place. The primary hypothesis is that the Ultrasound-guided CVC insertion is superior, with the higher overall success, higher first attempt success rate and with lower incidence of associated complications.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients within the age limit indicated for CVC insertion

排除标准

  • Outside the age limit

结局指标

主要结局

Overall success and first attempt success rate

时间窗: During CVC insertion

The overall success rate and first attempt success rate will be evaluated between ultrasound-guided and anatomical-based navigation

次要结局

  • Incidence of complications(24 hours from CVC insertion)
  • Time of insertion(During CVC insertion)

研究者

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

Petr Štourač, MD

assoc.prof.MD,Ph.D

Brno University Hospital

研究点 (1)

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