A Randomized Controlled Study to Explore the Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy
Overview
- Phase
- Not Applicable
- Intervention
- Rehabilitation therapy
- Conditions
- Traumatic Brain Injury
- Sponsor
- Zeng Changhao
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Concentration of albumin
- Status
- Terminated
- 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 (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.
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 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.
Arms & Interventions
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).
Intervention: Rehabilitation therapy
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).
Intervention: Intermittent Oro-esophageal Tube Feeding
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).
Intervention: Reserpine
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).
Intervention: Levofloxacin
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
Intervention: Rehabilitation therapy
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
Intervention: Nasogastric tube feeding
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
Intervention: Reserpine
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
Intervention: Levofloxacin
Outcomes
Primary Outcomes
Concentration of albumin
Time Frame: day 1 and day 28
albumin was tested with blood routine test
Nutritional status-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.
Concentration of hemoglobin
Time Frame: day 1 and day 28
hemoglobin was tested with blood routine test
Concentration of prealbumin
Time Frame: day 1 and day 28
prealbumin was tested with blood routine test
Secondary Outcomes
- Complications- Gastrointestinal Bleeding(up to 28 days)
- Decannulation of tracheostomy tube-placement duration(up to 28 days)
- Complications-Constipation(up to 28 days)
- Complications-Gastric Retention(up to 28 days)
- Complications-Diarrhea(up to 28 days)
- Complications-Pulmonary Infections(Day 1 and day 28)
- Complications-Gastroesophageal Reflux(up to 28 days)
- Decannulation of tracheostomy tube-Successful removal(up to 28 days)
- Level of consciousness(day 1 and day 28)