- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06220292
Intermittent Oral-esophageal Tube Feeding in Alzheimer's Patients With Dysphagia
Clinical Observation of Intermittent Oral-esophageal Tube Feeding in Alzheimer's Patients With Dysphagia: A Randomly Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Weijia Zhao, Doctor
- Phone Number: 17839973473
- Email: zwjww2009@163.com
Study Contact Backup
- Name: Zhefeng Wang
- Phone Number: 19501376864
- Email: zhengzhouzhj@qq.com
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450000
- Zheng Da first Yuan Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The observation group
During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups.
The observation group receives Intermittent Oral-esophageal Tube Feeding for enteral nutrition support
|
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.
The observation group was 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.
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.
|
Active Comparator: The control group
During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups.
The control group receives Nasogastric Tube Feeding for enteral nutrition support
|
Besides, the control group was given enteral nutritional support with Nasogastric tube according to the relevant guidelines.
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.
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin
Time Frame: day 1 and day 15
|
Hemoglobin was recorded through the blood routine test.
(Hb, g/L)
|
day 1 and day 15
|
Serum albumin
Time Frame: day 1 and day 15
|
Serum albumin was recorded through the blood routine test.
(ALB, g/L)
|
day 1 and day 15
|
Total serum protein
Time Frame: day 1 and day 15
|
Total serum protein was recorded through the blood routine test.
(TP, g/L)
|
day 1 and day 15
|
Serum prealbumin
Time Frame: day 1 and day 15
|
Serum prealbumin was recorded through the blood routine test.(PA,
g/L)
|
day 1 and day 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Video Fluoroscopic Swallowing Study
Time Frame: day 1 and day 15
|
Video Fluoroscopic Swallowing Study, which is considered as the "gold standard", swallowing process is divided into four periods: cognitive, oral, pharyngeal, and esophageal periods with a total score of 10 and a higher score indicates better swallowing ability (less dysphagia).
|
day 1 and day 15
|
Body Mass Index
Time Frame: day 1 and day 15, day 45, day 105, day 195
|
Body Mass Index was assessed with the combination of body weight and height: weight (kg)/ [height (m)] ^2
|
day 1 and day 15, day 45, day 105, day 195
|
Pulmonary Infections
Time Frame: day 1 and day 15, day 45, day 105, day 195
|
During 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.
|
day 1 and day 15, day 45, day 105, day 195
|
Mini Nutritional Assessment
Time Frame: day 1, day 45, day 105, day 195
|
Mini Nutritional Assessment is used for assessment of nutritional status, ranging 0 to 30.
A higher score indicates the better nutritional status
|
day 1, day 45, day 105, day 195
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nieto Luis, Doctor, Site Coordinator of United Medical Group located in Miami
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-KY-0109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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