Different Feeding in Traumatic Brain Injury Patients
A Randomized Controlled Study to Explore the Effect of Different Feeding in Traumatic Brain Injury Patients
1 other identifier
interventional
100
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 or the control group with Nasogastric tube feeding 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 Feb 2024
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
January 31, 2024
CompletedFirst Posted
Study publicly available on registry
February 8, 2024
CompletedStudy Start
First participant enrolled
February 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedMarch 7, 2024
March 1, 2024
3 months
January 31, 2024
March 5, 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
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 (4)
Decannulation of tracheostomy tube-placement duration
day 1 and day 28
Decannulation of tracheostomy tube-Successful removal
day 1 and day 28
Level of consciousness
day 1 and day 28
Feeding Amount
day 1 and day 28
Study Arms (2)
The observation group
EXPERIMENTALBoth groups of patients were provided with routine treatments, including pharmacological treatment, rehabilitation therapy.Based on this, the patients in the observation group 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).
The control group
ACTIVE COMPARATORBoth groups of patients were provided with routine treatments, including pharmacological treatment, rehabilitation therapy. The patients in the control group were provided nutrition support with Nasogastric tube feeding , while the feeding process strictly followed the relevant guideline
Interventions
Including: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.
Based on this, the patients in the observation group were given nutrition support with Intermittent Oro-esophageal Tube Feeding (Medical Device No. 20010234, developed by the Swallowing Disorders Research Institute of Zhengzhou University). The entire feeding process strictly followed the standard procedure of Intermittent Oro-esophageal Tube Feeding. 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.
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.
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 patients' 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
- Zeng Changhaolead
Study Sites (1)
Xinzhu Rehabilitation Hospital
Xinzhu, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nieto Luis, Master
Site Coordinator of United Medical Group located in Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Director
Study Record Dates
First Submitted
January 31, 2024
First Posted
February 8, 2024
Study Start
February 20, 2024
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
March 7, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share