Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Swallowing-Quality of Life questionnaire
研究概览
简要总结
The aim of this clinical trial is to compare the psychological condition and experience of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare the Social Condition and experience of the two groups.
详细描述
The study will last 15 days for each participant. The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Social Condition and Experience of two groups.
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 diagnostic criteria for ischemic stroke .
- •Dysphagia confirmed by video fluoroscopic Swallowing Study.
- •Clear consciousness.
- •Stable vital signs.
排除标准
- •Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, etc.
- •Complicated with severe liver and kidney failure, tumors, or hematological disorders.
- •Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
- •Pregnant or nursing females.
研究组 & 干预措施
comprehensive rehabilitation therapy+Intermittent Oro-esophageal Tube Feeding
Assigned randomly before the treatment, all patients were provided with comprehensive rehabilitation therapy.
The group is given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure. The feeding content was formulated by the nutritionists based on the condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups
干预措施: Intermittent Oro-esophageal Tube Feeding (Device)
comprehensive rehabilitation therapy+Intermittent Oro-esophageal Tube Feeding
Assigned randomly before the treatment, all patients were provided with comprehensive rehabilitation therapy.
The group is given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure. The feeding content was formulated by the nutritionists based on the condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups
干预措施: comprehensive rehabilitation therapy (Behavioral)
comprehensive rehabilitation therapy+Nasogastric Tube Feeding
Assigned randomly before the treatment, all patients were provided with comprehensive rehabilitation therapy.Besides, this group is given enteral nutritional support with Nasogastric Tube according to the relevant guidelines. Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation, the tube was secured to the cheek with medical tape. The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements.
干预措施: comprehensive rehabilitation therapy (Behavioral)
comprehensive rehabilitation therapy+Nasogastric Tube Feeding
Assigned randomly before the treatment, all patients were provided with comprehensive rehabilitation therapy.Besides, this group is given enteral nutritional support with Nasogastric Tube according to the relevant guidelines. Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation, the tube was secured to the cheek with medical tape. The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements.
干预措施: Nasogastric Tube Feeding (Device)
结局指标
主要结局
Swallowing-Quality of Life questionnaire
时间窗: day 1 and day 15
The Chinese version of the Swallowing-Quality of Life questionnaire (SWAL-QOL) was used to assess the quality of life of patients.he Likert scale ranging from 1 to 5 was utilized for scoring, with a total of 44 items, including difficulties in swallowing, dietary restrictions, oral health, social communication, and others. The total score was converted to a standard percentage scale ranging from 0 to 100, with positively correlated with quality of life.
次要结局
- The Reintegration to Normal Living Index(day 1 and day 15)
- Patient Health Questionnaire-9(day 1 and day 15)
- Functional Oral Intake Scale(day 1 and day 15)
研究者
Copka Sonpashan
The Research Director
Chao Phya Abhaibhubejhr Hospital