Clinical trial NCT02959450: Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia
Official title: Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia. Compared With Traditional Practice: Randomized Clinical Trial, Simple Blind
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oropharyngeal Dysphagia
Keywords: Nutritional Intervention in Oropharyngeal Dysphagia
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Adequacy of Oral Intake of Energy
timeFrame: 12 months
measure: Adequacy of Oral Intake of Protein
timeFrame: 12 months
Secondary outcomes:
measure: Body Weight
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Swallowing Ability
timeFrame: 12 months
measure: BMI
timeFrame: 12 months
Other outcomes:
Locations:
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Aurora E Serralde-Zúñiga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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