Oral Versus Nasal Enteral Nutrition on Severe Traumatic Brain Injury Patients With Tracheostomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Concentration of albumin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Concentration of albumin
时间窗: day 1 and day 28
albumin was tested with blood routine test
Nutritional status-body mass index
时间窗: 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
时间窗: day 1 and day 28
prealbumin was tested with blood routine test
Concentration of hemoglobin
时间窗: day 1 and day 28
hemoglobin was tested with blood routine test
次要结局
- Complications-Pulmonary Infections(day 1 and day 28)
- Complications- Gastrointestinal Bleeding(day 1 and day 28)
- Complications-Gastroesophageal Reflux(day 1 and day 28)
- Complications-Gastric Retention(day 1 and day 28)
- Complications-Constipation(day 1 and day 28)
- Complications-Diarrhea(day 1 and day 28)
- Decannulation of tracheostomy tube-placement duration(day 1 and day 28)
- Level of consciousness(day 1 and day 28)
研究者
Muhammad
Research Director
Ahmadu Bello University Teaching Hospital