Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- oro-pharyngeal swallowing efficiency
研究概览
简要总结
It was well known that long term intubation caused a various kind of abnormal presentations of dysphagia such as the increased aspiration risk, the decreased gag reflex, mucosal pathology, the airway stenosis and so on. It was thought that the freezing and impaired proprioception to be developed as a result of dis-use around the pharynx and the larynx while intubation was one of the reason.
Preemptive swallowing manual stimulation applied on the oral cavity to avoid the vicious cycle of dis-use was reported to improve dysphagia after extubation.
Neuromuscular electrical stimulation have been utilized for a wide variety of dysphagia of multiple causes of neuro-muscular disorder.
Supposing that preemptive transcutaneous neuromuscular electrical stimulation to be delivered to the muscles of being involved in swallowing could decrease the degree of dis-use during intubation so that it could reduce the occurence and severity of dysphagia developed after extubation, the investigators plan to perform randomized prospective double blind placebo controlled clinical interventional study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients to be admitted to the ICU due to the respiratory failure and intubated for at least 48 hours
排除标准
- •Past history of intubation
- •Past history or current status of traumatic brain injury
- •Past history or current status of symptomatic stroke
- •Past history or current status of injury of cranial nerves
- •Past history or current status of neuromuscular disorder
- •Patient not to be expected to be extubated
- •Patient to reject the participation
- •current usage of neuro-muscular blockers
结局指标
主要结局
oro-pharyngeal swallowing efficiency
时间窗: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
oro-pharyngeal swallowing efficiency was calculated by using the data derived from videofluoroscopic swallowing study
次要结局
- oral transit time(as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days)
- pharyngeal transit time(as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days)
- oro-pharyngeal transit time(as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days)
- swallowed volume(as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days)
- aspiration volume(as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days)
- presence of aspiration(as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days)
- presence of silent aspiration(as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days)
- penetration-aspiration scale(as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days)
研究者
Chang Ho Hwang
Clinical Associate Professor
Ulsan University Hospital