Oral Enteral Nutrition Feeding in Alzheimer's Patients

NCT ID: NCT06301750

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2024-06-30

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intermittent Oral-esophageal Tube Feeding group

This group is hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The Intermittent Oral-esophageal Tube Feeding group receives Intermittent Oral-esophageal Tube Feeding for enteral nutrition support

Group Type: EXPERIMENTAL

Conventional Care

Intervention Type: BEHAVIORAL

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.

Intermittent Oral-esophageal Tube Feeding

Intervention Type: DEVICE

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 group

This group is hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The Nasogastric tube group receives Nasogastric Tube Feeding for enteral nutrition support

Group Type: ACTIVE_COMPARATOR

Conventional Care

Intervention Type: BEHAVIORAL

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.

Nasogastric tube

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Intermittent Oral-esophageal Tube Feeding

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.

Intervention Type: DEVICE

Nasogastric tube

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muhammad

OTHER

Sponsor Role: lead

Responsible Party

Muhammad

Research Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nieto Luis, Master

Role: STUDY_CHAIR

Site Coordinator of United Medical Group

Central Contacts

Lavie Ce, Master

Role: CONTACT

zenghongjixx@qq.com

15333828388

Other Identifiers

Tube-Alzheimer

Identifier Type: -

Identifier Source: org_study_id