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
- 2
- 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)
研究组 & 干预措施
rectal trumpet
Patients meeting all study criteria will be randomized to either the rectal trumpet group or the standard treatment.
For placement of rectal trumpet (Rusch nasopharyngeal airway-32FR):
干预措施: Rusch Nasopharyngeal Airway (Device)
standard treatment
Patients meeting all study criteria will be randomized to either the rectal trumpet group or the standard treatment. The Numeric Pain Intensity Scale (0-10) or staff observation of physiological indicators (e.g., restlessness, sweating, tachycardia, lacrimation, pupil dilatation, poor ventilator synchrony) for disoriented or unresponsive patients will be used prior to and immediately after placement of either device in order to assess patient comfort. Comfort will be assessed every 8 hours on all oriented patients using the Numeric Pain Intensity Scale.
干预措施: Rusch Nasopharyngeal Airway (Device)
结局指标
主要结局
Skin integrity
次要结局
- Patient comfort
- Ease of use
- Cost effectiveness