- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06249022
Different Feeding in Traumatic Brain Injury Patients
March 5, 2024 updated by: Zeng Changhao
A Randomized Controlled Study to Explore the Effect of Different Feeding in Traumatic Brain Injury Patients
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The safe and effective nutrition support for severe traumatic brain injury patients with tracheostomy continues to be a challenge.
Nasogastric tube feeding has been the mainstream choice in China but with the risk of complications.
Intermittent Oro-esophageal Tube Feeding is an established modality of enteral nutrition support that can be used with routine treatment.
This study reports the clinical outcomes of Intermittent Oro-esophageal Tube Feeding vs. nasogastric tube feeding, in patients receiving routine treatment.
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.
Study Type
Interventional
Enrollment (Estimated)
100
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: Qianyun Lu, Master
- Phone Number: 19501376864
- Email: luqianyun@126.com
Study Contact Backup
- Name: Weijia Li, Master
- Email: liweijia@163.com
Study Locations
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Xinzhu, Taiwan
- Recruiting
- Xinzhu Rehabilitation Hospital
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Contact:
- Haim Liu
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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 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.
Exclusion Criteria:
- 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.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The observation group
Both 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).
|
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.
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Active Comparator: The control group
Both 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
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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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of hemoglobin
Time Frame: day 1 and day 28
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hemoglobin was tested with blood routine test
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day 1 and day 28
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Concentration of albumin
Time Frame: day 1 and day 28
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albumin was tested with blood routine test
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day 1 and day 28
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Concentration of prealbumin
Time Frame: day 1 and day 28
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prealbumin was tested with blood routine test
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day 1 and day 28
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body mass index
Time Frame: day 1 and day 28
|
body mass index was tested with body weight and height.
Combination was calculated as: body weight (kg) / height (m)^2.
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day 1 and day 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of consciousness
Time Frame: day 1 and day 28
|
The Glasgow Coma Scale was used to assess the level of consciousness in patients.
A score of 15 indicates normal consciousness, a score of 13-14 indicates mild consciousness impairment, a score of 9-12 indicates moderate consciousness impairment, and a score less than 8 indicates severe consciousness impairment.
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day 1 and day 28
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Decannulation of tracheostomy tube-placement duration
Time Frame: day 1 and day 28
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The duration of tracheostomy tube retention and the outcomes of decannulation were recorded for two groups during the treatment.
The criteria for tracheostomy tube removal were as follows: patients should exhibit no significant pulmonary complications (including the progressive decline in blood oxygen, carbon dioxide retention, pneumonia, etc.) during the capping trial, and should exhibit stable, regular breath and not require reintubation or tracheostomy within 72 hours after tube removal.
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day 1 and day 28
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Decannulation of tracheostomy tube-Successful removal
Time Frame: day 1 and day 28
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duration of tracheostomy tube retention and the outcomes of decannulation were recorded for two groups during the treatment.
The criteria for tracheostomy tube removal were as follows: patients should exhibit no significant pulmonary complications (including the progressive decline in blood oxygen, carbon dioxide retention, pneumonia, etc.) during the capping trial, and should exhibit stable, regular breath and not require reintubation or tracheostomy within 72 hours after tube removal
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day 1 and day 28
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Feeding Amount
Time Frame: day 1 and day 28
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total amount of nutrients consumed by the patient on the day was recorded, excluding fresh water, units: milliliters
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day 1 and day 28
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 20, 2024
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
January 31, 2024
First Submitted That Met QC Criteria
January 31, 2024
First Posted (Actual)
February 8, 2024
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOE-TBI xin
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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