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Swallowing and Nutritional Treatment on OD Patients

H

Hospital General de Mexico

Status

Unknown

Conditions

Oropharyngeal Dysphagia

Treatments

Other: Control
Other: Personalized diet

Study type

Interventional

Funder types

Other

Identifiers

NCT04132271
DI/19/301/03/003

Details and patient eligibility

About

Dysphagia is a difficulty during the swallowing process (transportation food from the mouth to the stomach. Oropharyngeal Dysphagia (OD) is diagnosed by videofluoroscopy and faringolaringoscopy. OD threatens the efficacy and safety of swallowing, contributing to an increased risk of aspiration and pneumonia. There are different interventions aimed to change and improve the physiology of swallowing; however, OD can be an important predictor of the progression of malnutrition in different types of patients. Malnutrition is defined as an acute or chronic disease whereby an energy imbalance, lack of energy, protein or other nutrients causes measurable and adverse effects on body composition, functional and clinical outcomes. In addition, it leads to a decrease in the quality of life.

Objective: To establish a strategy of nutritional treatment and swallowing rehabilitation in patients with dysphagia.

Hypothesis: An adequate nutritional intervention in content and consistency, combined with swallowing rehabilitation in patients with dysphagia, will improve the nutritional status and clinical evolution of patients with dysphagia.

Full description

Introduction: Dysphagia is a difficulty during the swallowing process (transportation food from the mouth to the stomach. Oropharyngeal Dysphagia (OD) is diagnosed by videoflouroscopy and faringolaringoscopy and it is frequently associated with neurodegenerative problems. OD threatens the efficacy and safety of swallowing, contributing to an increased risk of aspiration and pneumonia.

Problem statement: There are different interventions aimed to change and improve the physiology of swallowing; however, OD can be an important predictor of the progression of malnutrition in different types of patients. Malnutrition is defined as an acute or chronic disease whereby an energy imbalance, lack of energy, protein or other nutrients causes measurable and adverse effects on body composition, functional and clinical outcomes. In addition, it leads to a decrease in the quality of life.

Justification: It is essential to provide adequate nutritional interventions according to the specifications of the dysphagia in order to improve the nutritional status of these patients, as well to provide adequate early nutritional treatment when changing from tube to oral feeding, focusing on dietary factors that can significantly improve nutrition of the patient. However, there are no studies that evaluate the specific requirements for the nutritional treatment of these patients. By implementing a diet based on improving the safety and efficacy of swallowing in patients with OD, specific nutritional recommendations that impact on the rate of malnutrition and mortality of the different pathologies that present this condition could be established.

Objective: To establish a strategy of nutritional treatment and swallowing rehabilitation in patients with dysphagia.

Hypothesis: An adequate nutritional intervention in content and consistency, combined with swallowing rehabilitation in patients with dysphagia, will improve the nutritional status and clinical evolution of patients with dysphagia.

Methodology: This is a prospective randomized controlled clinical trial, in which OD patients will be recruited to participate. The participants will be receiving swallowing rehabilitation by a specialist phoniatrician. They will be randomise assigned to a special nutritional treatment during 12 weeks. Swallowing rehabilitation, laboratory analyses, anthropometric measurements and consume and quality of life questionaries will be carried out.

Enrollment

68 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Both sexes
  • 18 to 75 years old
  • Diagnosis of dysphagia
  • Full phonological assessment
  • Any federative entity in the country

Exclusion criteria

  • Patients with any nephropathy
  • HIV diagnosis
  • Thyroid dysfunction dignosis
  • Gastrostomy feeded patients
  • Patients on chemotherapy
  • Psychogenic Dysphagia

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

68 participants in 2 patient groups

Personalized diet
Experimental group
Description:
Personalized diet during the swallowing rehabilitation
Treatment:
Other: Personalized diet
Control
Active Comparator group
Description:
Nutritional recommendations during the swallowing rehabilitation
Treatment:
Other: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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