Intermittent Oral Tube in Alzheimer's Patients

NCT06328829 | Not Yet Recruiting

• 1 other identifier: IOE Alzheimer
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (5)

• Concentration of Hemoglobin

  Hemoglobin was recorded through the blood routine test. (Hb, g/L)

  day 1 and day 15

• Concentration of Serum albumin

  Serum albumin was recorded through the blood routine test. (ALB, g/L)

  day 1 and day 15

• Concentration of Total serum protein

  Total serum protein was recorded through the blood routine test. (TP, g/L)

  day 1 and day 15

• Concentration of Serum prealbumin

  Serum prealbumin was recorded through the blood routine test.(PA, g/L)

  day 1 and day 15

• 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

Secondary Outcomes (3)

• Pulmonary Infections

  day 1 and day 15

• Mini Nutritional Assessment

  day 1 and day 15

• Standardized Swallowing Assessment

  day 1 and day 15

Study Arms (2)

Conventional Care+Intermittent Oral-esophageal Tube Feeding

EXPERIMENTAL

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

Behavioral: Conventional Care; Device: Intermittent Oral-esophageal Tube Feeding

Conventional Care+Nasogastric tube

ACTIVE COMPARATOR

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

Behavioral: Conventional Care; Device: Nasogastric tube

Interventions

Conventional Care 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.

Conventional Care+Intermittent Oral-esophageal Tube Feeding; Conventional Care+Nasogastric tube

Intermittent Oral-esophageal Tube Feeding 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.

Conventional Care+Intermittent Oral-esophageal Tube Feeding

Nasogastric tube 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.

Conventional Care+Nasogastric tube

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copka Sonpashan: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Nieto Luis

  Site Coordinator of United Medical Group

  STUDY CHAIR

Central Study Contacts

Lavie Ce

CONTACT

15333828388; zengxizdyfy@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Research Director

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 25, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03