Swallowing and Nutritional Therapy and Its Impact on Body Composition and Clinical Outcomes in Patients With Post-extubation Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Muscle mass changes
研究概览
简要总结
The aim of this study is to evaluate the impact of the prescription of two doses of protein on the amount in kilograms of muscle mass and on the clinical evolution (time until safe swallowing, time until removal of the feeding stoma, number of hospital readmissions, feeding stoma infections, incidence of pneumonia, functionality, number of falls, fractures and mortality) at 6 months after hospital discharge in patients with enteral nutrition due to post-extubation dysphagia.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Amounts of protein was not revealed for participants
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who required invasive mechanical ventilation during their hospital stay with a diagnosis of post-extubation dysphagia diagnosed by fibroendoscopy evaluation of swallowing (FEES).
- •Patients who discharged with a feeding tube.
- •Patients with signed informed consent.
排除标准
- •Patients with pre-existing dysphagia, or with neurological conditions that can cause dysphagia (e.g. multiple sclerosis, Parkinson's disease, Alzheimer's, myasthenia gravis).
- •Patients with chronic kidney disease, defined as a glomerular filtration rate <60 ml/min.
- •Patients discharged with a terminal condition and/or life expectancy of less than 3 months.
- •Diagnosis of HIV, upon receiving clinical follow-up by the team of specialists.
结局指标
主要结局
Muscle mass changes
时间窗: From randomization to 6 months
Changes of muscle mass in kilograms measured by impedance bioelectric
次要结局
- Swallow recovery(From randomization to 6 months)
- Feeding tube complications(From randomization to 6 months)
- Muscle functionality changes(From randomization to 6 months)
- Duration of enteral nutrition indication(From randomization to 6 months)
- Frailty complications(From randomization to 6 months)
- 6-month mortality(From randomization to 6 months)
- Handgrip strenght changes(From randomization to 6 months)
- Aspiration pneumonia incidence(From randomization to 6 months)
- Hospital readmissions associated to dysphagia complications(From randomization to 6 months)
研究者
Ivan Armando Osuna Padilla
Clinical Nutrition Manager
National Institute of Respiratory Diseases, Mexico