Effect of Oral Enteral Nutrition on Severe Traumatic Brain Injury
- Conditions
- Traumatic Brain Injury
- Interventions
- Device: Intermittent Oro-esophageal Tube FeedingDevice: Nasogastric tube feedingBehavioral: Rehabilitation therapy
- Registration Number
- NCT06304012
- Lead Sponsor
- Muhammad
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nasogastric tube feeding+Rehabilitation therapy 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 Intermittent Oro-esophageal Tube Feeding+Rehabilitation therapy 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+Rehabilitation therapy Intermittent Oro-esophageal Tube Feeding 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). Nasogastric tube feeding+Rehabilitation therapy Nasogastric tube feeding 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
- Primary Outcome Measures
Name Time Method 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
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.
Concentration of prealbumin day 1 and day 28 prealbumin was tested with blood routine test
- Secondary Outcome Measures
Name Time Method 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.
Complications- Gastrointestinal Bleeding day 1 and day 28 Observing for any signs of bleeding within the digestive tract, which may manifest as blood in the stool or vomiting of blood.
Complications-Gastroesophageal Reflux day 1 and day 28 Gastroesophageal Reflux: Assessing the occurrence of reflux from the stomach into the esophagus, which can cause symptoms like heartburn and regurgitation.
Complications-Gastric Retention day 1 and day 28 Evaluating whether there was delayed emptying of the stomach contents, leading to symptoms such as bloating, nausea, and vomiting.
Complications-Constipation day 1 and day 28 Assessing the occurrence of infrequent bowel movements or difficulty passing stools.
Complications-Diarrhea day 1 and day 28 Monitoring for loose or watery stools, which may indicate gastrointestinal disturbances or medication side effects.
Decannulation of tracheostomy tube-placement duration day 1 and day 28 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.
Trial Locations
- Locations (1)
Jiansheng Hos.
🇨🇳Yilan, Taiwan