A Randomized Controlled Study to Explore the Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 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
- Double (Investigator, 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, indicating their full understanding of the study and agreement to participate.
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.
研究组 & 干预措施
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).
干预措施: Rehabilitation therapy (Behavioral)
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).
干预措施: Intermittent Oro-esophageal Tube Feeding (Device)
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).
干预措施: Reserpine (Drug)
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).
干预措施: Levofloxacin (Drug)
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
干预措施: Rehabilitation therapy (Behavioral)
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
干预措施: Nasogastric tube feeding (Device)
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
干预措施: Reserpine (Drug)
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
干预措施: Levofloxacin (Drug)
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 hemoglobin
时间窗: day 1 and day 28
hemoglobin was tested with blood routine test
Concentration of prealbumin
时间窗: day 1 and day 28
prealbumin was tested with blood routine test
次要结局
- 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)
研究者
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University