Different Feeding in Traumatic Brain Injury Patients
- Conditions
- Traumatic Brain Injury
- Interventions
- Behavioral: Rehabilitation therapyDevice: Nasogastric tube feedingDevice: Intermittent Oro-esophageal Tube Feeding
- Registration Number
- NCT06249022
- Lead Sponsor
- Zeng Changhao
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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 The observation group Rehabilitation therapy 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). The control group Rehabilitation therapy 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 The control group Nasogastric tube feeding 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 The observation group Intermittent Oro-esophageal Tube Feeding 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).
- 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
Concentration of prealbumin day 1 and day 28 prealbumin was tested with blood routine test
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 Outcome Measures
Name Time Method 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.
Decannulation of tracheostomy tube-Successful removal day 1 and day 28 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.
Feeding Amount day 1 and day 28 total amount of nutrients consumed by the patient on the day was recorded, excluding fresh water, units: milliliters
Trial Locations
- Locations (1)
Xinzhu Rehabilitation Hospital
🇨🇳Xinzhu, Taiwan