- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06328907
Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident
Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age>18 years.
- Meeting the diagnostic criteria for ischemic stroke .
- Dysphagia confirmed by video fluoroscopic Swallowing Study.
- Clear consciousness.
- Stable vital signs.
Exclusion Criteria:
- Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, etc.
- 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.
- Pregnant or nursing females.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: comprehensive rehabilitation therapy+Intermittent Oro-esophageal Tube Feeding
Assigned randomly before the treatment, all patients were provided with comprehensive rehabilitation therapy. The group is given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure. The feeding content was formulated by the nutritionists based on the 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 |
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.
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. |
Active Comparator: comprehensive rehabilitation therapy+Nasogastric Tube Feeding
Assigned randomly before the treatment, all patients were provided with comprehensive rehabilitation therapy.Besides, this group is 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 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 control group was given enteral nutritional support with Nasogastric Tube Feeding 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, 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 |
---|---|---|
Swallowing-Quality of Life questionnaire
Time Frame: day 1 and day 15
|
The Chinese version of the Swallowing-Quality of Life questionnaire (SWAL-QOL) was used to assess the quality of life of patients.he
Likert scale ranging from 1 to 5 was utilized for scoring, with a total of 44 items, including difficulties in swallowing, dietary restrictions, oral health, social communication, and others.
The total score was converted to a standard percentage scale ranging from 0 to 100, with positively correlated with quality of life.
|
day 1 and day 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire-9
Time Frame: day 1 and day 15
|
The total score of the Patient Health Questionnaire-9 ranges from 0 to 27, with higher scores indicating more severe depression symptoms.
|
day 1 and day 15
|
The Reintegration to Normal Living Index
Time Frame: day 1 and day 15
|
The Reintegration to Normal Living Index is a questionnaire used to assess the extent to which individuals have reintegrated into normal life following a stroke.
It includes various domains, including social aspects of reintegration.
The total score range for the scale is from 0 to 100, and a higher score indicates better reintegration into normal living.
Therefore, in the case of the scale, a higher score is considered more favorable as it reflects a greater degree of reintegration into normal life following a stroke.
|
day 1 and day 15
|
Functional Oral Intake Scale
Time Frame: day 1 and day 15
|
The Functional Oral Intake Scale reflects the patient's oral intake.
Studies have shown that this scale can also serve as an independent measure of intake for post-stroke dysphagia patients.
The scale is divided into 7 levels, with the level positively correlated with swallowing function.
Level 7 indicates normal swallowing function.
|
day 1 and day 15
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Other Study ID Numbers
- IOE Social Condition
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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