Alzheimer Disease
Conditions
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.
Interventions
BEHAVIORALConventional Care
Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. Pulmonary function training, including standing training, cough training, and diaphragm muscle training.
The observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure: Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm. However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.
DEVICENasogastric tube
Besides, the control group was given enteral nutritional support with Nasogastric tube according to the relevant guidelines. Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation, the tube was secured to the patient's cheek with medical tape. The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements. The feeding content was formulated by the nutritionists based on the patient's condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups. For patients with limited tube feeding compliance, we made appropriate adjustments to ensure that they were not at risk of severe malnutrition as much as possible.
Sponsors
Zeng Changhao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum prealbumin | day 1 and day 15 | Serum prealbumin was recorded through the blood routine test.(PA, g/L) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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 |
Countries
China
Outcome results
None listed