The Effect of Oro-esophageal Versus Nasogastric Feeding for Stroke Patients With Dysphagia: A Multicenter Randomized Controlled Large-Scale Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 422
- 主要终点
- Dysphagia Outcome and Severity Scale
研究概览
简要总结
This is a randomized controlled trial involving patients with ischemic stroke and dysphagia. The aim of this study is to explore the recovery speed and therapeutic effect of oro-esophageal feeding compared with nasogastric feeding on swallowing function. This study mainly addresses the following two research questions: 1. Whether oro-esophageal feeding improves swallowing function more rapidly and effectively than nasogastric tube feeding. 2. Whether oro-esophageal feeding is non-inferior to nasogastric tube feeding in terms of safety.
详细描述
This is a randomized controlled trial involving patients with ischemic stroke and dysphagia. The aim of this study is to explore the recovery speed and therapeutic effect of oro-esophageal feeding compared with nasogastric feeding on swallowing function. This study mainly addresses the following two research questions: 1. Whether oro-esophageal feeding improves swallowing function more rapidly and effectively than nasogastric tube feeding. 2. Whether oro-esophageal feeding is non-inferior to nasogastric tube feeding in terms of safety.
The intervention period will last for two weeks, with an additional four-week follow-up observation period. This is a multicenter study to be conducted across multiple hospitals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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.
- •First stroke
- •Disease duration less than one month.
- •Ischemic stroke.
- •Patients who need enteral feeding.
- •Dysphagia confirmed by imaging Study.
- •Clear consciousness.
- •Stable vital signs.
- •With informed consent and participants who understand and agree to comply with planned study procedures.
排除标准
- •Dysphagia that might be caused by other diseases or structural abnormalities.
- •Complicated with severe liver and kidney failure, tumors, or hematological disorders.
- •Contraindications for tube feeding.
- •Pregnancy or breast feeding.
- •Anticipated discharge from the hospital or transfer to another hospital within two week.
研究组 & 干预措施
Oro-esophageal Group
Participants will receive oro-esophageal feeding plus rehabilitation therapy in accordance with stroke rehabilitation guidelines, with the specific content determined by the participating centers, for 14 days and being hospitalized.
干预措施: Oro-esophageal Feeding (Dietary Supplement)
Oro-esophageal Group
Participants will receive oro-esophageal feeding plus rehabilitation therapy in accordance with stroke rehabilitation guidelines, with the specific content determined by the participating centers, for 14 days and being hospitalized.
干预措施: Rehabilitation care (Behavioral)
Nasogastric Group
Participants will receive Nasogastric feeding plus rehabilitation therapy in accordance with stroke rehabilitation guidelines, with the specific content determined by the participating centers, for 14 days and being hospitalized.
干预措施: Nasogastric Feeding (Dietary Supplement)
Nasogastric Group
Participants will receive Nasogastric feeding plus rehabilitation therapy in accordance with stroke rehabilitation guidelines, with the specific content determined by the participating centers, for 14 days and being hospitalized.
干预措施: Rehabilitation care (Behavioral)
结局指标
主要结局
Dysphagia Outcome and Severity Scale
时间窗: Day 0 and day15
The Dysphagia Outcome and Severity Scale consists of 7 levels, from 1 to 7, based on imaging data. A higher level indicates better swallowing function.
次要结局
- Time to improvement of one level and of the baseline Dysphagia Outcome and Severity Scale(up to 2 weeks)
- Time to oral intake(up to 2 weeks)
- Penetration-Aspiration Scale(Day 0 and day15)
- Murray Secretion Scale(Day 0 and day15)
- Yale Pharyngeal Residual Severity Rating Scale(Day 0 and day15)
- Aspiration(up to 6 weeks)
研究者
Zeng Changhao
Site Principle Manager
People's Hospital of Zhengzhou University