Skip to content

Intermittent Oral Tube in Alzheimer's Patients

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06328829
Enrollment
80
Registered
2024-03-25
Start date
2024-03-31
Completion date
2024-12-31
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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.

Interventions

BEHAVIORALConventional 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.

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.

DEVICENasogastric 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.

Sponsors

Copka Sonpashan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Body Mass Indexday 1 and day 15Body Mass Index was assessed with the combination of body weight and height: weight (kg)/ \[height (m)\] \^2
Concentration of Serum albuminday 1 and day 15Serum albumin was recorded through the blood routine test. (ALB, g/L)
Concentration of Total serum proteinday 1 and day 15Total serum protein was recorded through the blood routine test. (TP, g/L)
Concentration of Serum prealbuminday 1 and day 15Serum prealbumin was recorded through the blood routine test.(PA, g/L)
Concentration of Hemoglobinday 1 and day 15Hemoglobin was recorded through the blood routine test. (Hb, g/L)

Secondary

MeasureTime frameDescription
Mini Nutritional Assessmentday 1 and day 15Mini Nutritional Assessment is used for assessment of nutritional status, ranging 0 to 30. A higher score indicates the better nutritional status
Standardized Swallowing Assessmentday 1 and day 15The Standardized Swallowing Assessment Scale is a commonly used tool for evaluating swallowing function. It is widely applied in medical and rehabilitation fields to assess an individual's swallowing ability and the smooth passage of food/liquid through the esophagus. The scale ranges from 18 to 46, with lower scores indicating better swallowing function.
Pulmonary Infectionsday 1 and day 15During 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.

Contacts

Primary ContactLavie Ce
zengxizdyfy@126.com15333828388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026