Effect of Oral Enteral Nutrition on Severe Traumatic Brain Injury
Oral Versus Nasal Enteral Nutrition on Severe Traumatic Brain Injury Patients With Tracheostomy: A Randomized Controlled Trial
1 other identifier
interventional
104
1 country
1
Brief Summary
This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 5, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedMarch 12, 2024
March 1, 2024
12 months
March 5, 2024
March 9, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Concentration of hemoglobin
hemoglobin was tested with blood routine test
day 1 and day 28
Concentration of albumin
albumin was tested with blood routine test
day 1 and day 28
Concentration of prealbumin
prealbumin was tested with blood routine test
day 1 and day 28
Nutritional status-body mass index
body mass index was tested with body weight and height. Combination was calculated as: body weight (kg) / height (m)\^2.
day 1 and day 28
Secondary Outcomes (8)
Complications-Pulmonary Infections
day 1 and day 28
Complications-Gastroesophageal Reflux
day 1 and day 28
Complications- Gastrointestinal Bleeding
day 1 and day 28
Complications-Gastric Retention
day 1 and day 28
Complications-Diarrhea
day 1 and day 28
- +3 more secondary outcomes
Study Arms (2)
Intermittent Oro-esophageal Tube Feeding+Rehabilitation therapy
EXPERIMENTALBoth 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).
Nasogastric tube feeding+Rehabilitation therapy
ACTIVE COMPARATORBoth 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
Interventions
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.
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.
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
You may qualify if:
- age ≥ 18 years, meeting the diagnosis of severe Traumatic Brain Injury, confirmed through MRI
- 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.
You may not qualify if:
- unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;
- complicated with other intracranial lesions, such as stroke;
- with severe consciousness disorders caused by other diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Muhammadlead
Study Sites (1)
Jiansheng Hos.
Yilan, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nieto Luis, Master
Site Coordinator of United Medical Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Director
Study Record Dates
First Submitted
March 5, 2024
First Posted
March 12, 2024
Study Start
June 1, 2022
Primary Completion
May 17, 2023
Study Completion
June 1, 2023
Last Updated
March 12, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share