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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Completed

Conditions: Oropharyngeal Dysphagia

Treatments: Dietary Supplement: Modified consistency and volume diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02959450

1557

Details and patient eligibility

About

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.

Full 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.

Enrollment: 127 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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127 participants in 2 patient groups

Modified consistency and volume diet

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Modified consistency and volume diet

Control Group

No Intervention group

Description:

Standard treatment consisting of a modified consistency diet with adequate intake of energy and protein and general recommendations on diet prescribed by the treating physician