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

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362109
• Other study ID #: Once tubefeeding
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Chest Hospital, Ministry of Health and Welfare, Taiwan
• Contact: Laviena Ce
• Phone: 15422548954
• Email: linchuangzhuce[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

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

Device:
• Intermittent 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhao Song Ling

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional status-prealbumin	The 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.	Day 1 and day 15
Secondary	Nutritional status-albumin	The 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.	Day 1 and day 15
Secondary	Nutritional status-hemoglobin	The 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.	Day 1 and day 15