A Single-centre, Double Blind, Randomised Controlled Clinical Trial to Evaluate the Effect of Electrical Pharyngeal Stimulation as a Treatment for Stroke-related Dysphagia in Tracheostomized Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Readiness for decannulation
研究概览
简要总结
The purpose of this study is to evaluate whether electrical pharyngeal stimulation in addition to standard care can enhance short-term swallow recovery in tracheostomized dysphagic stroke patients and thereby facilitate earlier decannulation compared to sham treatment plus standard care.
详细描述
Readiness for decannulation is assessed after three days of either real or sham electrical pharyngeal stimulation. In case a patient cannot be decannulated at that time point, there is an open-label follow-up treatment phase, in which every patient in the sham treatment arm gets another three days of real electrical pharyngeal stimulation to not deprive any patient of a potentially beneficial treatment.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe dysphagia due to acute stroke
- •completely weaned from mechanical ventilation
- •impossibility of decannulation because of severe dysphagia with ongoing aspiration
排除标准
- •preexisting dysphagia
- •comorbidities that can possibly cause dysphagia
- •psychiatric comorbidities
- •pacemaker or other implanted electronic devices
研究组 & 干预措施
Electrical pharyngeal stimulation
Electrical pharyngeal stimulation once daily for 10 minutes on three consecutive days.
干预措施: Electrical pharyngeal stimulation (Device)
Sham stimulation
Sham stimulation once daily for 10 minutes on three consecutive days. If the subject cannot be decannulated after three days of sham stimulation, another three days of real electrical pharyngeal stimulation will be delivered.
干预措施: Sham stimulation (Device)
结局指标
主要结局
Readiness for decannulation
时间窗: 3 days
Difference in readiness for decannulation as assessed by a standardized fiberoptic endoscopic evaluation protocol after three days of treatment between real and sham treatment groups
次要结局
- Functional Oral Intake Scale (FOIS) at discharge(until discharge)
- length of stay on ICU / in the hospital and time from stimulation to discharge(until discharge)
- modified Rankin Scale (mRS) at discharge(until discharge)