Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- the score of Murray's secretion scale (MSS)
研究概览
简要总结
To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who met the diagnostic criteria for stroke formulated in the 4th National Academic Conference on Cerebrovascular disease;
- •patients with relatively stable vital signs, with a NIHSS score of 21 points;
- •patients with tracheotomy accompanied by dysphagia;
- •no previous history of dysphagia;
- •age ≥ 30 years and ≤80 years;
- •informed consent signed by the patient and his family.
排除标准
- •patients with medullary haemorrhage/infarction;
- •patients that experienced cerebral hernia and recurrent stroke;
- •patients with unstable arrhythmia, fever, infection, severe restlessness and inability to cooperate with treatment;
- •patients with gastro-oesophageal reflux, bilateral paralysis of the vocal cord, laryngopharyngeal stenosis/haemorrhage/tumour;
- •patients in which there was an inability to accurately locate epiglottis and arytenoid cartilage due to throat disease;
- •patients with a history of epilepsy or risk of seizures.
研究组 & 干预措施
control group
Based on receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy.
干预措施: Conventional air-pulse stimulation (Behavioral)
trial group
The trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy.
干预措施: Modified Air-pulse Stimulation (Behavioral)
结局指标
主要结局
the score of Murray's secretion scale (MSS)
时间窗: 2 weeks
MSS
the score of penetration-aspiration scale (PAS)
时间窗: 2 weeks
PAS
the score of Fiberoptic endoscopic examination of swallowing (FEES)
时间窗: 2 weeks
Fiberoptic endoscopic examination of swallowing
次要结局
- the score of Clinical Pulmonary Infection Score (CPIS)(2 weeks)