Effect of Oral Enteral Nutrition on Severe Traumatic Brain Injury
NCT ID: NCT06304012
Last Updated: 2024-03-12
Study Results
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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COMPLETED
NA
104 participants
INTERVENTIONAL
2022-06-01
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intermittent Oro-esophageal Tube Feeding+Rehabilitation therapy
Both groups of patients were provided with routine treatments. Based on this, the patients were given enteral nutrition support with Intermittent Oro-esophageal Tube Feeding (Medical Device No. 20010234, developed by the Swallowing Disorders Research Institute of Zhengzhou University).
Intermittent Oro-esophageal Tube Feeding
The entire feeding process strictly followed the standard procedure of Intermittent Oro-esophageal Tube Feeding(18). During the feeding process, patients were maintained in a semi-recumbent position with their head elevated, facilitating the placement of the tube into the oral cavity along one side, with the chin brought close to the manubrium sterni.
Rehabilitation therapy
Acupuncture: Regular acupuncture treatment that can prevent muscle atrophy, improve circulation, and have a stimulating effect.
Exercise therapy: Training that focused on limb movements or joint mobilization to prevent muscle contracture, reduce joint mobility, improve spasms, and promote blood circulation.
Others: Regular turning, back patting, and position changes performed by caregivers.
Nasogastric tube feeding+Rehabilitation therapy
Both groups of patients were provided with routine treatments The group was provided nutrition support with Nasogastric tube feeding , while the feeding process strictly followed the relevant guideline
Nasogastric tube feeding
The patients in the control group were provided nutrition support with Nasogastric tube feeding, while the feeding process strictly followed the relevant guideline. During the treatment, the patients remained in a continuous state of tube indwelling, receiving feeding every 2-3 hours with a maximum feeding volume of 200ml, of which the contents were consistent with the observation group. The entire feeding process was conducted by trained nursing staff. Besides, the tube was replaced by a new one every 5-7 days.
Rehabilitation therapy
Acupuncture: Regular acupuncture treatment that can prevent muscle atrophy, improve circulation, and have a stimulating effect.
Exercise therapy: Training that focused on limb movements or joint mobilization to prevent muscle contracture, reduce joint mobility, improve spasms, and promote blood circulation.
Others: Regular turning, back patting, and position changes performed by caregivers.
Interventions
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Nasogastric tube feeding
The patients in the control group were provided nutrition support with Nasogastric tube feeding, while the feeding process strictly followed the relevant guideline. During the treatment, the patients remained in a continuous state of tube indwelling, receiving feeding every 2-3 hours with a maximum feeding volume of 200ml, of which the contents were consistent with the observation group. The entire feeding process was conducted by trained nursing staff. Besides, the tube was replaced by a new one every 5-7 days.
Intermittent Oro-esophageal Tube Feeding
The entire feeding process strictly followed the standard procedure of Intermittent Oro-esophageal Tube Feeding(18). During the feeding process, patients were maintained in a semi-recumbent position with their head elevated, facilitating the placement of the tube into the oral cavity along one side, with the chin brought close to the manubrium sterni.
Rehabilitation therapy
Acupuncture: Regular acupuncture treatment that can prevent muscle atrophy, improve circulation, and have a stimulating effect.
Exercise therapy: Training that focused on limb movements or joint mobilization to prevent muscle contracture, reduce joint mobility, improve spasms, and promote blood circulation.
Others: Regular turning, back patting, and position changes performed by caregivers.
Eligibility Criteria
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Inclusion Criteria
* score of Glasgow Coma Scale (GCS) \<8;
* presence of no contraindication for enteral nutrition;
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;
* informed consent form was obtained from the patient\'s family members.
Exclusion Criteria
* complicated with other intracranial lesions, such as stroke;
* with severe consciousness disorders caused by other diseases.
18 Years
ALL
No
Sponsors
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Muhammad
OTHER
Responsible Party
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Muhammad
Research Director
Principal Investigators
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Nieto Luis, Master
Role: STUDY_CHAIR
Site Coordinator of United Medical Group
Locations
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Jiansheng Hos.
Yilan, , Taiwan
Countries
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Other Identifiers
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IOE-TBI lao
Identifier Type: -
Identifier Source: org_study_id
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