A Randomized Controlled Study to Explore the Effect of Different Feeding in Traumatic Brain Injury Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- Zeng Changhao
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Concentration of hemoglobin
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Concentration of hemoglobin
Time Frame: day 1 and day 28
hemoglobin was tested with blood routine test
Concentration of albumin
Time Frame: day 1 and day 28
albumin was tested with blood routine test
Concentration of prealbumin
Time Frame: day 1 and day 28
prealbumin was tested with blood routine test
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.
Secondary Outcomes
- 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)