NCT02195713已完成不适用
Evaluation of a Novel Electronic Urine Output Monitor (eUOM)
Potrero Medical2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Urine Output of SOC Device Versus Accuryn
研究概览
简要总结
Urine output and urine drain line pressure were monitored while urine was drained into either:
- Accuryn Urine Output Monitor (Potrero Medical) OR
- Criticore Monitor (Bard Medical)
详细描述
The purpose of this study is to determine the characteristics of urine output and drain line pressure as measured with the Accuryn urinary output monitoring system and urine output as recorded by a commercially available system (Criticore, Bard Medical) when used with a standard Foley catheter and standard urinary drainage tube.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must ≥ 18 years of age
- •Patient has a Foley catheter and urine collection system is in place per standard clinical decision
- •Estimated length of placement of the Foley is 48 hours minimum
- •Burn injury ≥ 20% and ≤ 80% total body surface area (TBSA)
- •Subject or subject's legally authorized representative is able to give informed consent before entering the study
排除标准
- •Currently pregnant or breastfeeding
- •Clinical signs or symptoms of a urinary tract infection (UTI)
- •Clinical signs or symptoms of a vaginal infection
- •Currently has bladder or urethral trauma
- •Use of investigational drug/device therapy within the past 4 weeks
结局指标
主要结局
Urine Output of SOC Device Versus Accuryn
时间窗: 2 - 5 days
Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube.
次要结局
未报告次要终点
研究者
研究点 (2)
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