Clinical Application of Comprehensive Intervention Scheme for Post-extubation Dysphagia Based on Neuroregulatory Mechanism
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- standardized Swallowing Assessment（SSA）
研究概览
简要总结
This study aims to establish a practical comprehensive intervention program for dysphagia after extubation in adult ICU patients based on the best evidence of its assessment and intervention, through expert panel discussion and Delphi method. In addition, combining the preliminary experimental results of vagus nerve stimulation applied to PED patients, we further develop a comprehensive intervention program for dysphagia after extubation based on neural regulation mechanism. Finally, the implementation effect of this PED comprehensive intervention program based on neural regulation mechanism will be verified through clinical application.
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
- None
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
- •Patients who met the diagnostic criteria of PED were changed to SSA score ≥24
- •aged from 18 to 90 years old;
- •oral or nasotracheal intubation for ≥48 hours;
- •Glasgow score ≥13 points, with good cooperation ability;
- •There was no contraindication to oral feeding after extubation
排除标准
- •Other diseases that affect swallowing function (such as stroke, Parkinson's disease, head and neck deformity, radiotherapy after head and neck cancer, burn with inhalation injury, esophageal cancer, chronic obstructive pulmonary disease, etc.);
- •history of reflux and aspiration;
- •tracheotomy;
- •isolation treatment due to respiratory infectious diseases;
- •the presence of implantable electronic devices (e.g., pacemakers, cochlear implants);
- •Traumatic vagus recurrent laryngeal nerve injury, history of vagus nerve surgery, or vagus nerve injury
结局指标
主要结局
standardized Swallowing Assessment（SSA）
时间窗: up to 90 days
The first part is the clinical examination.The second part involves observing the patient's ability to swallow 5 mL of water, repeated three times. If there are no abnormalities detected in the above examinations, the amount of water for swallowing is then increased to 60 mL. To obtain the total score, the scores from all three parts are summed up.
functional oral intake scale（FOIS）
时间窗: up to 90 days
FOIS consists of seven levels: ① Score 1, unable to eat orally at all; ② Score 2, dependent on tube feeding, minimum attempt to eat food or liquid; ③ Score 3, dependent on tube feeding, taking single texture food or liquid orally; ④ Score 4, completely oral intake of single texture food; ⑤ score 5: fully oral intake of a variety of food textures, but with special preparation or compensation; ⑥6 points, completely oral feeding without special preparation, but with special food restriction; ⑦7 points, complete oral feeding without restriction, the higher the score, the better the swallowing function of the patient. In this study, a FOIS score of 6-7 was defined as full oral feeding
次要结局
- Rate of total oral feeding after the intervention(up to 90 days)
- Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh)(up to 90 days)
- Rate of Re-intubation after Endotracheal Intubation(up to 90 days)
- Incidence of aspiration within one week after extubation(up to 90 days)
- Inflammation-related indicators: serum interleukin-6 (IL-6)(up to 90 days)
- Inflammation-related indicators: high mobility group box-1 protein (HMGB1)(up to 90 days)
- In-hospital survival rate(up to 90 days)
- Duration of Enteral Nutrition Tube Indwelling(up to 90 days)
- Inflammation-related indicators: serum C-reactive protein (CRP)(up to 90 days)
- Total days of hospitalization(up to 90 days)
- The incidence of aspiration pneumonia within one week after extubation(up to 90 days)
- Days of ICU hospitalization(up to 90 days)