Clinical trial NCT06220292: Intermittent Oral-esophageal Tube Feeding in Alzheimer's Patients With Dysphagia
Official title: Clinical Observation of Intermittent Oral-esophageal Tube Feeding in Alzheimer's Patients With Dysphagia: A Randomly Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hemoglobin
timeFrame: day 1 and day 15
measure: Serum albumin
timeFrame: day 1 and day 15
measure: Total serum protein
timeFrame: day 1 and day 15
measure: Serum prealbumin
timeFrame: day 1 and day 15
Secondary outcomes:
measure: Video Fluoroscopic Swallowing Study
timeFrame: day 1 and day 15
measure: Body Mass Index
timeFrame: day 1 and day 15, day 45, day 105, day 195
measure: Pulmonary Infections
timeFrame: day 1 and day 15, day 45, day 105, day 195
measure: Mini Nutritional Assessment
timeFrame: day 1, day 45, day 105, day 195
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zheng Da first Yuan Hospital
state: Henan
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Doctor
role: PRINCIPAL_INVESTIGATOR
References: