Clinical Observation of Intermittent Oral-esophageal Tube Feeding in Alzheimer's Patients With Dysphagia: A Randomly Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Hemoglobin
研究概览
简要总结
This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.
详细描述
The Alzheimer's disease in the elderly exhibits the high prevalence.This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 years and 85 years, meeting the diagnosis of Alzheimer's Disease.
- •presence of no contraindication for enteral nutrition.
- •with dysphagia verified by Imaging materials.
- •with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications
- •Minimum Mental State Examination ranging from 10-26
排除标准
- •unable to cooperate in completing treatment and assessment due to personal reasons or other disorders.
- •complicated with other intracranial lesions, such as stroke.
- •abnormal structure of swallowing-related organ and tissue.
结局指标
主要结局
Hemoglobin
时间窗: day 1 and day 15
Hemoglobin was recorded through the blood routine test. (Hb, g/L)
Serum albumin
时间窗: day 1 and day 15
Serum albumin was recorded through the blood routine test. (ALB, g/L)
Total serum protein
时间窗: day 1 and day 15
Total serum protein was recorded through the blood routine test. (TP, g/L)
Serum prealbumin
时间窗: day 1 and day 15
Serum prealbumin was recorded through the blood routine test.(PA, g/L)
次要结局
- Body Mass Index(day 1 and day 15, day 45, day 105, day 195)
- Pulmonary Infections(day 1 and day 15, day 45, day 105, day 195)
- Video Fluoroscopic Swallowing Study(day 1 and day 15)
- Mini Nutritional Assessment(day 1, day 45, day 105, day 195)
研究者
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University