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临床试验/NCT01235078
NCT01235078已完成不适用

An Observational Study of Intraosseous Vascular Access Compared to Central Venous Catheters in the Emergency Department

Vidacare Corporation6 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2010年4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
105
试验地点
6
主要终点
Time to vascular access

研究概览

简要总结

The purpose of this study is to evaluate the use of powered intraosseous vascular access (EZ-IO by Vidacare) in the emergency department for patients requiring urgent vascular access. Data collected will be compared to historical data on central venous catheter use in the emergency department. The primary hypothesis is that powered intraosseous vascular access will decrease the amount of time needed to obtain vascular access.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients requiring vascular access who would otherwise receive a central venous catheter due to lack of other options.

排除标准

  • Fracture in target bone, or significant trauma to the site
  • Excessive tissue and/or absence of adequate anatomical landmarks in target bone
  • Infection in target area
  • IO insertion in past 24 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone

结局指标

主要结局

Time to vascular access

时间窗: at time of patient's arrival to emergency department, average within 10 minutes

Time from opening intraosseous device packaging to initial infusion of drugs or fluids via the intraosseous route.

次要结局

  • Incidence of complications with intraosseous device(time subject has intraosseous vascular access, an average of 24 hours)

研究者

发起方
Vidacare Corporation
申办方类型
Industry
责任方
Sponsor

研究点 (6)

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