Intermittent Oral-esophageal Tube Feeding in Alzheimer's Patients With Dysphagia

Alzheimer Disease Clinical Trial

Official title:

Clinical Observation of Intermittent Oral-esophageal Tube Feeding in Alzheimer's Patients With Dysphagia: A Randomly Controlled Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06220292
• Other study ID #: 2024-KY-0109
• Status: Withdrawn
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: August 15, 2024

Study information

• Verified date: March 2024
• Source: People's Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 15, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Behavioral:
• Conventional 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.

Device:
• Intermittent Oral-esophageal Tube Feeding
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.
• Nasogastric 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.

Locations

Country	Name	City	State
China	Zheng Da first Yuan Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zeng Changhao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin	Hemoglobin was recorded through the blood routine test. (Hb, g/L)	day 1 and day 15
Primary	Serum albumin	Serum albumin was recorded through the blood routine test. (ALB, g/L)	day 1 and day 15
Primary	Total serum protein	Total serum protein was recorded through the blood routine test. (TP, g/L)	day 1 and day 15
Primary	Serum prealbumin	Serum prealbumin was recorded through the blood routine test.(PA, g/L)	day 1 and day 15
Secondary	Video Fluoroscopic Swallowing Study	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).	day 1 and day 15
Secondary	Body Mass Index	Body Mass Index was assessed with the combination of body weight and height: weight (kg)/ [height (m)] ^2	day 1 and day 15, day 45, day 105, day 195
Secondary	Pulmonary Infections	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.	day 1 and day 15, day 45, day 105, day 195
Secondary	Mini Nutritional Assessment	Mini Nutritional Assessment is used for assessment of nutritional status, ranging 0 to 30. A higher score indicates the better nutritional status	day 1, day 45, day 105, day 195