A Clinical Comparison of the Rectal Trumpet and Standard Care in Acutely Ill Patients With Fecal Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Skin integrity
研究概览
简要总结
Primary: To determine the effectiveness of the rectal trumpet compared to the standard care in maintaining skin integrity in patients with fecal incontinence.
Hypothesis (H1): There will be no difference in the failure rates of rectal area skin integrity between subjects receiving the rectal trumpet and those receiving treatment as usual (staqndard care).
Secondary: To determine the ease of use, cost-effectiveness, and level of patient comfort with the rectal trumpet compared to the standard care in patients with fecal incontinence.
Secondary (exploratory) hypotheses:
There will be differences in the ease of use of the devices, costs of the devices, and patient comfort relative to the devices.
详细描述
Method:
Subjects:
A convenience sample of 80 adult male and female patients in the Wilmington Intensive Care Unit (WICU), Surgical Critical Care Center (SCCC), Medical Intensive Care Unit (MICU), and 6D Step-Down, TSU, 5A, 5E/W, will be recruited. After obtaining informed consent, subjects will be randomized to one of two groups (experimental: rectal trumpet or standard treatment: Hollister fecal incontinent collector).
Inclusion Criteria: Patients who meet the following criteria:
- Diarrhea - two episodes of loose or watery stool in a 12 hour period
- ≥ 18 years of age
- English-speaking patient or guardian
- Intact skin, may be discolored without breakdown
- Doctor's order for rectal trumpet (if randomized to treatment group)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Diarrhea - two episodes of loose or watery stool in a 12 hour period
- •≥ 18 years of age
- •English-speaking patient or guardian
- •Intact skin, may be reddened without breakdown
- •Doctor's order for rectal trumpet if patient randomized to treatment group
排除标准
- •prolapsed anal sphincter
- •active rectal bleeding
- •colorectal cancer
- •bleeding precautions
- •rectal tone rated 1 (gaping) or 2 (lax)
结局指标
主要结局
Skin integrity
次要结局
- Ease of use
- Cost effectiveness
- Patient comfort