DysphagiaNCT06362109
The Impact of Intermittent Nutritional Tube Supplementation in Elderly Patients With Dysphagia
A study testing Routine rehabilitation and Intermittent Oro-esophageal Tube Feeding in people with Dysphagia, run by Zhao Song Ling.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Routine rehabilitation and Intermittent Oro-esophageal Tube Feeding
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>60 years.
- Dysphagia confirmed by Videofluoroscopic Swallowing Study.
- Clear consciousness.
- Stable vital signs.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Intermittent Nutritional Tube Supplementation in Elderly Patients With Dysphagia: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Dysphagia
- Being tested
- Routine rehabilitation, Intermittent Oro-esophageal Tube Feeding
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine rehabilitationBehavioural
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.
Intermittent Oro-esophageal Tube FeedingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine rehabilitation group | Active comparator | This group is going to receive Routine rehabilitation once a day. Receives: Behavioral: Routine rehabilitation |
| Routine rehabilitation + Intermittent Oro-esophageal Tube Feeding group | Experimental | This group is going to receive Routine rehabilitation once a day and Intermittent Oro-esophageal Tube Feeding once a day. Receives: Behavioral: Routine rehabilitation; Device: Intermittent Oro-esophageal Tube Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 and day 15
Secondary outcomes (2)
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.
Measured: Day 1 and day 15
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.
Measured: Day 1 and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhao Song Ling
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Zhao Song Ling, Chest Hospital, Ministry of Health and Welfare, Taiwan
- Investigators
- Louis Wi, Study chair, Site Coordinator of United Medical Group located in Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362109
- Sponsor's protocol ID
- Once tubefeeding
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intermittent Nutritional Tube Supplementation in Elderly Patients With Dysphagia: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06362109
- Acronym / sponsor ID
- Once tubefeeding
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhao Song LingOther government
- Study start
- Apr 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine rehabilitation group | Active comparator | Behavioral: Routine rehabilitationThis group is going to receive Routine rehabilitation once a day. |
| Routine rehabilitation + Intermittent Oro-esophageal Tube Feeding group | Experimental | Behavioral: Routine rehabilitation, Device: Intermittent Oro-esophageal Tube FeedingThis group is going to receive Routine rehabilitation once a day and Intermittent Oro-esophageal Tube Feeding once a day. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>60 years.
- Dysphagia confirmed by Videofluoroscopic Swallowing Study.
- Clear consciousness.
- Stable vital signs.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine rehabilitationRoutine 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. | Behavioural | Routine rehabilitation + Intermittent Oro-esophageal Tube Feeding group, Routine rehabilitation group |
| Intermittent Oro-esophageal Tube FeedingThe 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. | Device | Routine rehabilitation + Intermittent Oro-esophageal Tube Feeding group |
Primary outcome
Nutritional status-prealbumin
Time frame: Day 1 and day 15
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.
2 secondary outcomes
Nutritional status-albumin
Time frame: Day 1 and day 15
Nutritional status-hemoglobin
Time frame: Day 1 and day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Wi study chair
Site Coordinator of United Medical Group located in Miami
Questions about this trial
What is this clinical trial studying?
A study testing Routine rehabilitation and Intermittent Oro-esophageal Tube Feeding in people with Dysphagia, run by Zhao Song Ling.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laviena Ce (15422548954, linchuangzhuce@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status-prealbumin (time frame: Day 1 and day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.