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

NCT06220292 | Withdrawn DMC

• 1 other identifier: 2024-KY-0109
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 (4)

• Hemoglobin

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

  day 1 and day 15

• Serum albumin

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

  day 1 and day 15

• Total serum protein

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

  day 1 and day 15

• Serum prealbumin

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

  day 1 and day 15

Secondary Outcomes (4)

• Video Fluoroscopic Swallowing Study

  day 1 and day 15

• Body Mass Index

  day 1 and day 15, day 45, day 105, day 195

• Pulmonary Infections

  day 1 and day 15, day 45, day 105, day 195

• Mini Nutritional Assessment

  day 1, day 45, day 105, day 195

Study Arms (2)

The observation group

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

The control group

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.

The control group; The observation group

Intermittent Oral-esophageal Tube Feeding DEVICE

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.

The observation group

Nasogastric tube DEVICE

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.

The control group

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

• Zeng Changhao: lead

Study Sites (1)

Zheng Da first Yuan Hospital

Zhengzhou, Henan, 450000, China

Location

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, Doctor

  Site Coordinator of United Medical Group located in Miami

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 23, 2024
• Study Start: January 30, 2024
• Primary Completion: July 30, 2024
• Study Completion: August 15, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)