NCT02470078已完成不适用
Randomised Controlled Trial of Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke Patients
University Hospital Muenster2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pneumonia rate
研究概览
简要总结
The purpose of this study is to evaluate whether pharyngeal electrical stimulation in addition to standard care can enhance swallowing recovery in severely dysphagic stroke patients post extubation compared to sham treatment plus standard care.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe dysphagia post extubation due to acute stroke
排除标准
- •preexisting dysphagia
- •comorbidities that can possibly cause dysphagia
- •psychiatric comorbidities
- •pacemaker or other implanted electronic devices
结局指标
主要结局
Pneumonia rate
时间窗: 120 hours
Incidence of aspiration pneumonia within 120 hours from extubation
Reintubation rate
时间窗: 120 hours
Need for reintubation within 120 hours from extubation
次要结局
- Time until oral nutrition(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Length of stay(Participants will be followed for the duration of stay on the intensive care unit, an expected average of 3 weeks)
- PEG tube placement(Participants will be followed for the duration of hospital stay, an expected average of 5 weeks.)
- Swallowing function(after 3 days of treatment)
研究者
研究点 (2)
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