Intermittent Oral-esophageal Tube Feeding in Alzheimer's Patients With Dysphagia
- Conditions
- Alzheimer Disease
- Interventions
- Behavioral: Conventional CareDevice: Intermittent Oral-esophageal Tube FeedingDevice: Nasogastric tube
- Registration Number
- NCT06220292
- Lead Sponsor
- Zeng Changhao
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The control group Conventional Care 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 The observation group 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 The observation group Conventional Care 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 The control group 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
- Primary Outcome Measures
Name Time Method Hemoglobin day 1 and day 15 Hemoglobin was recorded through the blood routine test. (Hb, g/L)
Serum albumin day 1 and day 15 Serum albumin was recorded through the blood routine test. (ALB, g/L)
Total serum protein day 1 and day 15 Total serum protein was recorded through the blood routine test. (TP, g/L)
Serum prealbumin day 1 and day 15 Serum prealbumin was recorded through the blood routine test.(PA, g/L)
- Secondary Outcome Measures
Name Time Method Body Mass Index day 1 and day 15, day 45, day 105, day 195 Body Mass Index was assessed with the combination of body weight and height: weight (kg)/ \[height (m)\] \^2
Pulmonary Infections day 1 and day 15, day 45, day 105, day 195 During the treatment, the occurrence of complications was recorded for both groups. These complications included but were not limited to: 1) Pulmonary Infections: Monitoring for the development of respiratory infections such as pneumonia or bronchitis.
Video Fluoroscopic Swallowing Study day 1 and day 15 Video Fluoroscopic Swallowing Study, which is considered as the "gold standard", swallowing process is divided into four periods: cognitive, oral, pharyngeal, and esophageal periods with a total score of 10 and a higher score indicates better swallowing ability (less dysphagia).
Mini Nutritional Assessment day 1, day 45, day 105, day 195 Mini Nutritional Assessment is used for assessment of nutritional status, ranging 0 to 30. A higher score indicates the better nutritional status
Trial Locations
- Locations (1)
Zheng Da first Yuan Hospital
🇨🇳Zhengzhou, Henan, China