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The Impact of Intermittent Nutritional Tube Supplementation in Elderly Patients With Dysphagia

The Impact of Intermittent Nutritional Tube Supplementation in Elderly Patients With Dysphagia: A Randomized Controlled Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06362109
Enrollment
80
Registered
2024-04-12
Start date
2024-04-30
Completion date
2024-12-31
Last updated
2024-04-12

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

Conditions

Dysphagia

Brief summary

This is a prospective, randomized controlled clinical trail involved Elderly Patients With Dysphagia.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding in Elderly Patients With Dysphagia. The main questions it aims to answer: Can Intermittent Nutritional Tube Supplementation help improve the nutritional status in Elderly Patients With Dysphagia. Participants will be divided into two groups randomly. All patients are given routine rehabilitation and the intervention group is given Intermittent Oro-esophageal Tube Feeding once a day.

Detailed description

The current situation of dysphagia in elderly individuals is characterized by difficulty or discomfort in swallowing. This condition can occur due to various factors such as muscle weakness, neurological disorders, or structural abnormalities in the throat or esophagus. Dysphagia can lead to complications such as malnutrition, dehydration, aspiration pneumonia, and reduced quality of life. It is important for healthcare professionals to assess and manage dysphagia in elderly patients to ensure proper nutrition and prevent potential health risks. This is a prospective, randomized controlled clinical trail involved Elderly Patients With Dysphagia.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding in Elderly Patients With Dysphagia. The main questions it aims to answer: Can Intermittent Nutritional Tube Supplementation help improve the nutritional status in Elderly Patients With Dysphagia. Participants will be divided into two groups randomly. All patients are given routine rehabilitation and the intervention group is given Intermittent Oro-esophageal Tube Feeding once a day.

Interventions

Routine rehabilitation consists of: 1. Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. 2. Swallowing training, including lemon ice stimulation, empty swallowing training, and pronunciation training. 3. Pulmonary function training, including standing training, cough training, and diaphragm muscle training.

DEVICEIntermittent Oro-esophageal Tube Feeding

The group is 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.

Sponsors

Zhao Song Ling
Lead SponsorOTHER_GOV

Study design

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

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age\>60 years. * Dysphagia confirmed by Videofluoroscopic Swallowing Study. * Clear consciousness. * Stable vital signs.

Exclusion criteria

* Complicated with severe liver and kidney failure, tumors, or hematological disorders. * Simultaneously in need to undergo other therapy that might affect the outcomes of this study.

Design outcomes

Primary

MeasureTime frameDescription
Nutritional status-prealbuminDay 1 and day 15The relevant indicators include prealbumin (PA, mg/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach ones and in the morning.

Secondary

MeasureTime frameDescription
Nutritional status-albuminDay 1 and day 15The relevant indicators include albumin (ALB, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach ones and in the morning.
Nutritional status-hemoglobinDay 1 and day 15The relevant indicators include hemoglobin (Hb, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach ones and in the morning.

Contacts

Primary ContactLaviena Ce
linchuangzhuce@126.com15422548954
Backup ContactWei Zhao
zwjww2009@163.com13303321354

Outcome results

None listed

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