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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia. Compared With Traditional Practice: Randomized Clinical Trial, Simple Bli

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 Summary:

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.


Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Current Primary Outcome: Adequacy of oral intake of energy and protein [ Time Frame: 3 months ]

The percentage of oral intake of energy and protein by the patient in contrast with the prescription


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Body weight [ Time Frame: 3 months ]
    The percentage of body weight increase in the intervention group in contrast with the control group
  • Swallowing ability [ Time Frame: 3 months ]
    Change in swallowing ability measured by clinical volume-viscosity swallowing test


Original Secondary Outcome: Same as current

Information By: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Dates:
Date Received: November 7, 2016
Date Started: May 2015
Date Completion: October 2017
Last Updated: November 8, 2016
Last Verified: November 2016