- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06211777
Effect of Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on Dysphagia Patients After Stroke
March 2, 2024 updated by: Zeng Changhao
Effect of Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on Dysphagia Patients After Stroke: A Prospective Multicenter Study
This was a prospective multicenter study.
the patients after stroke with were randomly divided into the observation group and the control group.
All patients were given comprehensive rehabilitation therapy.
During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively.
Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
Dysphagia in patients after stroke continues to be a challenge.
To avoid the wound caused by gastrostomy, nasogastric tube feeding has been the mainstay of palliation, but potential side effects exist this choice.
Intermittent Oro-esophageal tube feeding is an established modality that can be used with comprehensive rehabilitation therapy.
This study reports the outcomes of Intermittent Oro-esophageal tube feeding and comparison with nasogastric tube feeding, including nutritional status, dysphagia, quality of life, depression, and follow-up in patients receiving comprehensive rehabilitation therapy.This was a prospective multicenter study.
the patients after stroke with were randomly divided into the observation group and the control group.
All patients were given comprehensive rehabilitation therapy.
During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively.
Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhefeng Wang, Doctor
- Phone Number: 19501376864
- Email: zhengzhouzhj@qq.com
Study Contact Backup
- Name: Weiji Zhao, Master
- Phone Number: 17839973473
- Email: zwjww2009@163.com
Study Locations
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Henan
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Zhengzhou, Henan, China, 450000
- Zheng da yi fu yuan hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age ≥ 18 years;
- meeting the diagnostic criteria of stroke;
- any degree of dysphagia at admission;
- steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
- transferred out within three weeks of hospitalization in the neurology department.
Exclusion Criteria:
- complicated with other neurological diseases;
- damaged mucosa or incomplete structure in nasopharynx;
- tracheostomy tube plugged;
- unfeasible to the support of parenteral nutrition;
- simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
Study lasts 15 days for each patient.
The patients were given comprehensive rehabilitation therapy.
The observation group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding.
|
The specific procedure was as follows: the infant was placed in a semi-recumbent or sitting position with the head fixed.
Before each feeding, the infant's oral and nasal secretions were to be cleared.
An intermittent oro-esophageal tube was appropriately lubricated with water on the head part.
The professional medical staff held the tube and slowly inserted it through one side of the mouth into the upper part of the esophagus.
The depth of insertion depended on the patient's age and height.
After each feeding, the tube was immediately removed, and the patient was held upright for at least 30 minutes in case of reflux.
Both groups were given comprehensive rehabilitation therapy.
The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time.
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Active Comparator: the control group
Study lasts 15 days for each patient.
The patients were given comprehensive rehabilitation.
The observation group was provided the support of enteral nutrition by Nasogastric Tube Feeding.
|
Both groups were given comprehensive rehabilitation therapy.
The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time.
Nasogastric Tube Feeding were used for feeding to provide nutritional support.
Each feeding was administered by a nurse using the infant's mother's breast milk through the tube.
The amount of each feeding varied from 20 to 100 ml depending on the age of the infant, with feedings given every 2 to 3 hours, approximately 10 times per day.
The duration of each feeding procedure ranged from 10 to 20 minutes.
The total daily intake ranged from 200 to 1000 ml.
Each tube was kept indwelling for 5 to 7 days.
When the tube needed to be replaced, it was removed after the last feeding of a day and a new tube was to be inserted through the other nostril on the following morning to continue the nutritional support.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Penetration-Aspiration Scale
Time Frame: day 1 and day 15
|
Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process.
The scores ranged 1 point to 8 points.
As the level increased, the severity of dysphagia also increased.
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day 1 and day 15
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutritional status-total protein
Time Frame: day 1 and day 15
|
The relevant indicators include total protein (TP, g/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning.
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day 1 and day 15
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Nutritional status-albumin
Time Frame: day 1 and day 15
|
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 infants and in the morning.
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day 1 and day 15
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Body weight
Time Frame: day 1 and day 15
|
Body weight measurement of the infants was conducted by the same nurse according to the relevant standards.
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day 1 and day 15
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Yale pharyngeal residue severity rating scale
Time Frame: day 1 and day 15
|
The Yale pharyngeal residue severity rating scale was recruited for assessment, of which the result would be divided into 5 levels (1, no residue; 2, the covered pharyngeal mucosa; 3, mild residue, less than 50%; 4, moderate residue, more than 50%; 5, severe residue, spillage from laryngeal vestibule observed).As the level increased, the severity of dysphagia also increased.
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day 1 and day 15
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Patient health questionnaire-9
Time Frame: day 1 and day 15
|
The depression of the patients was evaluated with the patient health questionnaire-9.
The scores ranged 0-27.
As the scores increased, the severity of depression also increased.
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day 1 and day 15
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Swallowing Quality of Life questionnaire
Time Frame: day 1 and day 15
|
Swallowing Quality of Life questionnaire was used to evaluate the quality of life, which consists of 44 items and divided into 11 main domains, including: overall satisfaction, understanding, diet, hydration, communication, respiratory issues, postoperative recovery, social impact, mental health, saliva control, and appearance.
The maximum rough score was 220 points, which was converted into a standard percentage system in our study.
As the scores increased, the quality of life was better.
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day 1 and day 15
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nieto Luis, Master, Site Coordinator of United Medical Group located in Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2024
Primary Completion (Estimated)
March 10, 2024
Study Completion (Estimated)
April 1, 2024
Study Registration Dates
First Submitted
January 7, 2024
First Submitted That Met QC Criteria
January 7, 2024
First Posted (Actual)
January 18, 2024
Study Record Updates
Last Update Posted (Actual)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 2, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-KY-1225
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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