Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia

Not Applicable

Completed

Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Modified consistency and volume diet	Modified consistency and volume diet	Modified consistency diet, with a certain viscosity and controlled volume. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP.

Primary Outcome Measures

Name	Time	Method
Adequacy of Oral Intake of Energy	12 months	The energy intake measured in kcal/kg/d
Adequacy of Oral Intake of Protein	12 months	The protein intake measured in protein g/kg/d

Secondary Outcome Measures

Name	Time	Method
BMI	12 months	Body mass index at the end of study
Body Weight	12 months	The total of kg of body weight in the intervention group in contrast with the control group at 12 months of follow-up
Swallowing Ability	12 months	Patient's swallowing ability evaluated by volume-viscosity test, if patient is able to swallow correctly the three types of consistencies (liquid, nectar and pudding)
Mortality	12 months	number of deaths at 12 months of follow-up