Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia. Compared With Traditional Practice: Randomized Clinical Trial, Simple Blind
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Oropharyngeal Dysphagia
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Enrollment
- 127
- Locations
- 1
- Primary Endpoint
- Adequacy of Oral Intake of Energy
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Aurora Elizabeth Serralde Zúñiga
MD, PhD
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Oropharyngeal Dysphagia.
- •Patients who have primary caregiver.
- •Agreeing to participate in the study.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Adequacy of Oral Intake of Energy
Time Frame: 12 months
The energy intake measured in kcal/kg/d
Adequacy of Oral Intake of Protein
Time Frame: 12 months
The protein intake measured in protein g/kg/d
Secondary Outcomes
- BMI(12 months)
- Body Weight(12 months)
- Swallowing Ability(12 months)
- Mortality(12 months)