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

NCT ID: NCT06362109

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Routine rehabilitation group

This group is going to receive Routine rehabilitation once a day.

Group Type ACTIVE_COMPARATOR

Routine rehabilitation

Intervention Type BEHAVIORAL

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.

Routine rehabilitation + Intermittent Oro-esophageal Tube Feeding group

This group is going to receive Routine rehabilitation once a day and Intermittent Oro-esophageal Tube Feeding once a day.

Group Type EXPERIMENTAL

Routine rehabilitation

Intervention Type BEHAVIORAL

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.

Intermittent Oro-esophageal Tube Feeding

Intervention Type DEVICE

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.

Interventions

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Routine rehabilitation

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.

Intervention Type BEHAVIORAL

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhao Song Ling

OTHER_GOV

Sponsor Role lead

Responsible Party

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Zhao Song Ling

Research Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Louis Wi

Role: STUDY_CHAIR

Site Coordinator of United Medical Group located in Miami

Central Contacts

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Laviena Ce

Role: CONTACT

15422548954

Wei Zhao

Role: CONTACT

13303321354

Other Identifiers

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Once tubefeeding

Identifier Type: -

Identifier Source: org_study_id

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