Evaluating the Effects of Intermittent Oro-esophageal in Tracheotomy Patients With Neurogenic Dysphagia: a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Decannulation time of the tracheostomy tube
研究概览
简要总结
Neurogenic dysphagia refers to swallowing disorders caused by the damage of swallowing central or peripheral nerves and muscles. According to statistics, about 50% of patients with neurological diseases will be complicated with neurogenic dysphagia. Common diseases include stroke, dementia, Parkinson's disease and neuromuscular diseases. Dysphagia has a great impact on the quality of life of patients, and is related to malnutrition, aspiration pneumonia and even death. In severe cases, tracheotomy is required to maintain airway patency and discharge secretions. The common nutritional support methods for patients with neurogenic dysphagia after tracheotomy are nasogastric or nasointestinal tube placement and percutaneous gastrostomy.
intermittent oro-esophageal tube feeding (IOE) is a new nutrition method proposed by scholars in recent years. Studies have shown that it can improve the swallowing function of patients with dysphagia while meeting the nutritional needs of patients, so as to effectively improve the quality of life of patients. However, there are few studies on patients with dysphagia after tracheotomy. This study aims to compare the intervention effects of two kinds of tube feeding methods in patients with neurogenic dysphagia after tracheotomy.
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 92 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of neurogenic dysphagia；
- •Acute phase has passed, weaning time > 48 hours, tracheotomy time >1 week; in accordance with the decannulation process of tracheotomy patients formulated by our center in 2018;
- •steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment；
- •Gastrointestinal motility is good, can tolerate more than 150ml/h feeding pump speed;
- •Willing to sign an informed consent form.
排除标准
- •Structural swallowing disorders, such as oral, pharyngeal, larynx, esophagus and other anatomical abnormalities caused by swallowing disorders;
- •The clinical condition was unstable, accompanied by heart, lung, brain and other important organ dysfunction;
- •Severe cognitive dysfunction, confusion, unable to cooperate.
研究组 & 干预措施
NGT group
Intranasal continuous nasogastric tube or nasogastric tube nutritional support was used. For patients at risk of repeated aspiration and regurgitation, patients with gastric nutritional intolerance who could not be improved by using gastrointestinal motility drugs, intestinal indentation tube and retropyloric feeding were given.
干预措施: Naso-intestinal tube nutrition support (Procedure)
IOE group
Disposable gastric tube was used for enteral nutrition support
干预措施: intermittent oro-esophageal (Procedure)
结局指标
主要结局
Decannulation time of the tracheostomy tube
时间窗: From date of randomization until extubation, assessed up to 30 days
Decannulation time of the tracheostomy tube, corresponding to the number of days between entering the decannulation protocol to removal.
次要结局
- Decannulation rate(From date of randomization until extubation, assessed up to 30 days)
- Penetration-Aspiration Scale (PAS) score(up to 30 days)
- Nutritional status-albumin(ALB, g/L), prealbumin (PA, mg/L) and body mass index (BMI)(up to 30 days)
- ChSwallowing Quality of Life questionnaire (ChSWAL-QoL)(up to 30 days)
研究者
Jingyi Ge
Principal Investigator
Capital Medical University