Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice in Swallowing in Elderly Patients With Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The pharyngeal clearance score (1-5)
研究概览
简要总结
The texture of the pureed diet is likely to be most useful factor predictive of the prevention of aspiration pneumonia. However, it has not been previously reported what kinds of texture of the pureed diet can prevent aspiration pneumonia. Using endoscopic swallowing evaluation, we attempt to compare two kinds of the pureed diets to choose the better texture of pureed diets in elderly patients with severe dysphagia.
详细描述
The degree of dysphagia is evaluated using Hyodo.Komagane score (0-12). Subsequently, a randomized, crossover trial using pureed rice containing a gelling agent (Softia U, Nutri Co., Ltd., Yokkaichi, Japan), or standard pureed rice is performed in patients with dysphagia.
The extent of pharyngeal clearance after swallowing of each pureed rice and test jelly (Isotonic green jelly®, Nutri Co., Ltd., Yokkaichi, Japan) is scored as follows:
- No remains
- Pharyngeal clearance is obtained after swallowing of test jelly once
- Pharyngeal clearance is obtained after swallowing of test jelly twice
- Pharyngeal clearance is obtained after swallowing of test jelly three times and more
- In spite of swallowing of test jelly, pharyngeal residues remain and/or penetrate into larynx.
Evaluation Primary outcome: The pharyngeal clearance score (1-5) Secondary outcome: Patient feeling regarding pharyngeal clearance after the swallowing of pureed rice and/or test jelly (0 remains -100% complete clearance)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hospitalized patients who underwent endoscopic swallowing evaluation at Showa Inan General Hospital
排除标准
- •an age less than 65 years old or the presence of an acute infection.
研究组 & 干预措施
pureed rice with a gelling agent
3 ml of pureed rice containing a gelling agent is attempted to swallow under endoscopic examination of swallowing
干预措施: a gelling agent (Other)
standard pureed rice
3 ml of standard pureed rice is attempted to swallow under endoscopic examination of swallowing
干预措施: a gelling agent (Other)
结局指标
主要结局
The pharyngeal clearance score (1-5)
时间窗: 24 months
1. No remains 2. Pharyngeal clearance is obtained after swallowing of test jelly once 3. Pharyngeal clearance is obtained after swallowing of test jelly twice 4. Pharyngeal clearance is obtained after swallowing of test jelly three times and more 5. In spite of swallowing of test jelly, pharyngeal residues remain and/or penetrate into larynx.
次要结局
- Patient feeling regarding pharyngeal clearance(24 months)
研究者
Akira Horiuchi
Chief of Digestive Disease Center
Showa Inan General Hospital