Clinical Observation of Intermittent Oral-esophageal Tube Feeding in Alzheimer's Patients With Dysphagia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Concentration of Total serum protein
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
- Single (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.
研究组 & 干预措施
Conventional Care+Intermittent Oral-esophageal Tube Feeding
During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The observation group receives Intermittent Oral-esophageal Tube Feeding for enteral nutrition support
干预措施: Conventional Care (Behavioral)
Conventional Care+Intermittent Oral-esophageal Tube Feeding
During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The observation group receives Intermittent Oral-esophageal Tube Feeding for enteral nutrition support
干预措施: Intermittent Oral-esophageal Tube Feeding (Device)
Conventional Care+Nasogastric tube
During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The control group receives Nasogastric Tube Feeding for enteral nutrition support
干预措施: Conventional Care (Behavioral)
Conventional Care+Nasogastric tube
During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The control group receives Nasogastric Tube Feeding for enteral nutrition support
干预措施: Nasogastric tube (Device)
结局指标
主要结局
Concentration of Total serum protein
时间窗: day 1 and day 15
Total serum protein was recorded through the blood routine test. (TP, g/L)
Concentration of Serum prealbumin
时间窗: day 1 and day 15
Serum prealbumin was recorded through the blood routine test.(PA, g/L)
Body Mass Index
时间窗: day 1 and day 15
Body Mass Index was assessed with the combination of body weight and height: weight (kg)/ \[height (m)\] \^2
Concentration of Hemoglobin
时间窗: day 1 and day 15
Hemoglobin was recorded through the blood routine test. (Hb, g/L)
Concentration of Serum albumin
时间窗: day 1 and day 15
Serum albumin was recorded through the blood routine test. (ALB, g/L)
次要结局
- Pulmonary Infections(day 1 and day 15)
- Mini Nutritional Assessment(day 1 and day 15)
- Standardized Swallowing Assessment(day 1 and day 15)
研究者
Copka Sonpashan
The Research Director
Chao Phya Abhaibhubejhr Hospital