Effects of Oro-esophageal Versus Nasogastric Tubes on Swallowing Function in Ischemic Stroke Survivors: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 主要终点
- Penetration-Aspiration Scale
研究概览
简要总结
This is an open-label randomized controlled trial. The participants are ischemic stroke patients requiring enteral nutrition. The study is conducted in the Department of Rehabilitation Medicine and Department of Neurology.
The purpose of this study is to explore the effects of Intermittent Oro-esophageal Tube Feeding versus Nasogastric Tube Feeding on participants' swallowing function and airway protection.
Specifically, the study aims to answer the following two key questions:
Is there any difference between the two feeding methods in terms of their effects on swallowing function? Are the safety profiles of the two feeding methods consistent? Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.
Participants will be divided into two groups randomly, with different nutritional support respectively.
详细描述
This is a two-arm open-label randomized controlled trial. The participants are dysphagic ischemic stroke patients requiring enteral nutrition. The study is conducted in the Department of Rehabilitation Medicine and Department of Neurology.
The purpose of this study is to explore the effects of Intermittent Oro-esophageal Tube Feeding versus Nasogastric Tube Feeding on participants' swallowing function and airway protection.
Specifically, the study aims to answer the following two key questions:
Is there any difference between the two feeding methods in terms of their effects on swallowing function? Are the safety profiles of the two feeding methods consistent? Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.
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
- 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.
- •Patients who need enteral feeding.
- •Dysphagia confirmed by Videofluoroscopic 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, myasthenia gravis, 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.
结局指标
主要结局
Penetration-Aspiration Scale
时间窗: Day 0 and day 15
The Penetration-Aspiration Scale is for assessing airway protection. It has 8 grades, grouped into 3 categories: no penetration/aspiration, penetration, aspiration. Lower grades = better function: Grade 1 is optimal (no airway entry); Grade 8 is most severe (food enters airway below vocal cords with no clearing effort).
Dysphagia Outcome and Severity Scale
时间窗: Day 0 and day 15
The Dysphagia Outcome and Severity Scale is a key tool for grading the severity of swallowing disorders and evaluating functional outcomes in patients. It has 7 grades, ranging from severe swallowing impairment to normal swallowing function. Higher grades = better function: Grade 1 means no safe oral intake at all; Grade 7 represents normal swallowing with no restrictions or compensatory strategies.
次要结局
- Functional Oral Intake Scale(Day 0 and day 15)
研究者
Zeng Changhao
Principle Investigator
People's Hospital of Zhengzhou University