Chronic Indwelling Foley and Catheter Associated Trauma (CIF-CAT) Study
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 主要终点
- Bladder mucosa damage assessment via computerized image analysis
研究概览
简要总结
To determine whether an indwelling low profile Kohli Atraumatic Catheter causes less macro-morphologic inflammation and edema to the bladder mucosa than a traditional indwelling Foley catheter as assess by computerized image analysis.
详细描述
The Kohli Atraumatic Catheter similarly aims to reduce bladder mucosal trauma with its low profile pancake shaped balloon versus the ovoid balloon of a traditional Foley catheter. The Kohli Atraumatic Catheter has a short, opened-ended tip that minimally protrudes through a patented low-profile donut-shaped balloon. The combination of the low profile and reduced tip length prevents the catheter from contacting the bladder walls and thereby minimize disruption of the bladder surface mucus layer and trauma to the urothelium - theoretically reducing the chance of bacterial invasion. A trial in which sheep were randomized to a traditional indwelling Foley catheter or a prototype Kohli Atraumatic Catheter demonstrated a dramatic reduction in both bladder wall trauma and edema. The ulcerated area dropped from 7.2% to 1.8% (75%) and the edema from 26.9% to 13.0% (52%).
Statistical Analysis To compare the effects of 2 catheter types, data will be analyzed using the general linear models tools from SAS/STAT software and presented as means ± standard error of the mean. The model will include 2 catheter types, inflamed vs non-inflamed areas, and their interactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or Women older than age 18
- •Indwelling Foley urinary catheter for at least 30 days prior to entry with anticipation for continued indwelling urinary catheterization for at least 30 days after entry into the study.
排除标准
- •Inability to provide informed consent
- •Unwilling or medically inappropriate for cystoscopy
研究组 & 干预措施
Cystoscopic Inspection
Comparison of bladder damage with traditional Foley catheter and the Kohli Atraumatic catheter.
Interventions: cystoscopy
干预措施: cystoscopy (Device)
结局指标
主要结局
Bladder mucosa damage assessment via computerized image analysis
时间窗: 30 days
Macro-morphologic inflammation and edema assessment of bladder mucosa using computerized image analysis. Image Analysis Technique Image of each bladder will be analyzed using FLIR Research IR Software (FLIR Systems Inc., Wilsonville, OR) to determine the proportion of inflamed areas characterized by red surface including hemorrhage and ulceration, and edema (eg, swollen smooth surface) out of total bladder area.
次要结局
- Patient discomfort via Numeric Pain Rating Scale(30 days)
- Bladder mucosa damage urologist visual assessment(30 days)