Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia. Compared With Traditional Practice: Randomized Clinical Trial, Simple Blind
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Adequacy of Oral Intake of Energy
研究概览
简要总结
The purpose of this trial is to design, implement and evaluate the effect of a nutritional intervention in patients with Oropharyngeal Dysphagia on body composition and oral intake of energy and protein.
详细描述
Oropharyngeal Dysphagia causes complications that compromise the efficacy and security of deglutition. An inefficacy deglutition increases the risk of malnutrition and/or dehydration. On the other hand, unsafe deglutition requires more time to complete the oral preparation of the bolus, which can leave residues in the mouth that can then lead to penetration of small food particles into the respiratory tract. These tracheobronchial aspirations cause aspiration pneumonia in 50% of cases, with 50% of mortality rate.
Despite the enormous impact of Oropharyngeal Dysphagia in functional capacity and quality of life, this problem is underestimated and underdiagnosed as a major cause of nutritional and pulmonary complications that generate more material and human resources. There are few studies evaluating the effect of a nutritional intervention on recovery in swallowing ability or improvement of nutritional status.
The purpose of this trial is to design a nutritional intervention with modified texture foods to increase viscosity (measured accurately) according to the patient's requirements, also assess if the intervention has a positive effect on the swallowing ability, calorie and protein oral intake and nutritional status.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Oropharyngeal Dysphagia.
- •Patients who have primary caregiver.
- •Agreeing to participate in the study.
排除标准
- •Critically ill patients.
- •Chronic kidney disease with Glomerular Filtration Rate <30 ml / min or in renal replacement therapy
- •Liver failure.
- •Cancer with active radiotherapy or chemotherapy treatment.
- •Patients who are participating in another study.
结局指标
主要结局
Adequacy of Oral Intake of Energy
时间窗: 12 months
The energy intake measured in kcal/kg/d
Adequacy of Oral Intake of Protein
时间窗: 12 months
The protein intake measured in protein g/kg/d
次要结局
- BMI(12 months)
- Body Weight(12 months)
- Swallowing Ability(12 months)
- Mortality(12 months)
研究者
Aurora Elizabeth Serralde Zúñiga
MD, PhD
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran