Traumatic Brain Injury
Conditions
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.
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 (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.
Interventions
BEHAVIORALRehabilitation therapy
1. Acupuncture: Regular acupuncture treatment that can prevent muscle atrophy, improve circulation, and have a stimulating effect. 2. Exercise therapy: Training that focused on limb movements or joint mobilization to prevent muscle contracture, reduce joint mobility, improve spasms, and promote blood circulation. 3. Others: Regular turning, back patting, and position changes performed by caregivers.
DEVICEIntermittent Oro-esophageal Tube Feeding
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(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.
DEVICENasogastric 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.
DRUGReserpine
Reserpine was administered to patients to nourish their nerves, with frequency based on their condition.
DRUGLevofloxacin
The levofloxacin was administered to patients as antibiotic treatment, with frequency based on their condition.
Sponsors
Zeng Changhao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
This was a prospective multicenter randomized controlled study, including severe Traumatic Brain Injury patients with tracheostomy transferred to the department of rehabilitation medicine in 3 hospitals from intensive care unit in China between June 2022 and June 2023. Patients enrolled were firstly numbered and then randomly divided into the observation group and the control group. In addition to routine treatments, Intermittent Oro-esophageal Tube Feeding or Nasogastric tube feeding, as nutrition support, was given to patients based on their group. The study lasted 4 weeks for each patient.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 patient's family members, indicating their full understanding of the study and agreement to participate.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of hemoglobin | day 1 and day 28 | hemoglobin was tested with blood routine test |
| Concentration of albumin | day 1 and day 28 | albumin was tested with blood routine test |
| Concentration of prealbumin | day 1 and day 28 | prealbumin was tested with blood routine test |
| Nutritional status-body mass index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications-Diarrhea | up to 28 days | Monitoring for loose or watery stools, which may indicate gastrointestinal disturbances or medication side effects. |
| Complications-Constipation | up to 28 days | Assessing the occurrence of infrequent bowel movements or difficulty passing stools. |
| Complications-Pulmonary Infections | Day 1 and day 28 | During the treatment, the occurrence of complications was recorded for both groups(24). These complications included but were not limited to: 1) Pulmonary Infections: Monitoring for the development of respiratory infections such as pneumonia or bronchitis. |
| Decannulation of tracheostomy tube-Successful removal | up to 28 days | 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 |
| Level of consciousness | 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. |
| Decannulation of tracheostomy tube-placement duration | up to 28 days | 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. |
| Complications-Gastroesophageal Reflux | up to 28 days | Gastroesophageal Reflux: Assessing the occurrence of reflux from the stomach into the esophagus, which can cause symptoms like heartburn and regurgitation. |
| Complications- Gastrointestinal Bleeding | up to 28 days | Observing for any signs of bleeding within the digestive tract, which may manifest as blood in the stool or vomiting of blood. |
| Complications-Gastric Retention | up to 28 days | Evaluating whether there was delayed emptying of the stomach contents, leading to symptoms such as bloating, nausea, and vomiting. |
Countries
China
Outcome results
None listed