Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Bacteriuria
研究概览
简要总结
The purpose of this study is to see if there are differences in urine drainage between two types of indwelling bladder catheter systems (Foley catheter) in hospitalized patients. The difference between the two catheters is that one catheter is vented (the study catheter) and the other is a standard non-vented catheter. The vented catheter may drain urine better than a standard non-vented catheter.
If a vented catheter drains the bladder better than a non-vented catheter it may lower the risk of retained urine in the bladder which could help prevent urinary tract infections.
详细描述
During hospitalization, while in the surgical intensive care unit beginning the day after surgery, measurements of the subject's urine drainage system will be taken at daily study visits: retained urine volume, dependent loops, incidence of bacteriuria, and thigh diameter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for a planned surgery
- •Anticipated indwelling bladder catheter placement for greater than 24 hours
- •Anticipated post-op admission to a surgical ICU
排除标准
- •Unstable renal function as self-reported
- •Anticipated bandaged postoperative suprapubic incisions
- •Anatomical deformity that precludes appropriate suprapubic access for ultrasound bladder scanning
- •Surgical procedure that prevents accurate core body temperature by any means other than by bladder temperature
研究组 & 干预措施
Vented urinary drainage system
This group will be catheterized with a vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
干预措施: Vented urinary drainage system (Device)
Non-vented urinary drainage system
This group will be catheterized with a non-vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
干预措施: Non-vented urinary drainage system (Device)
结局指标
主要结局
Bacteriuria
时间窗: 7 days
Evidence of bacteriuria, a potential precursor to Catheter Associated Urinary Tract Infection (CAUTI), will be used to study the potential effect of the vented urinary drainage system intervention on CAUTI.
次要结局
- Retained Urine(7 days)
- Presence of biofilms in catheter materials(7 days)