An interventional study of High protein dose and Usual protein dose in Dysphagia, sponsored by National Institute of Respiratory Diseases, Mexico. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-19.
Sponsored by National Institute of Respiratory Diseases, Mexico · Not applicable, Interventional, and Treatment
The aim of this study is to evaluate the impact of the prescription of two doses of protein on the amount in kilograms of muscle mass and on the clinical evolution (time until safe swallowing, time until removal of the feeding stoma, number of hospital readmissions, feeding stoma infections, incidence of pneumonia, functionality, number of falls, fractures and mortality) at 6 months after hospital discharge in patients with enteral nutrition due to post-extubation dysphagia.
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's planned enrollment of 128 is above the median of 60 across 471 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →National Institute of Respiratory Diseases, Mexico is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
100% of the energy requirements measured by indirect calorimetry (IC) or estimated, and a protein intake of 2.0 g/kg, will be prescribed
Other: High protein dose
100% of the energy requirements measured by IC or estimated, and a protein intake of 1.5 g/kg, will be prescribed.
Other: Usual protein dose
High dose of protein (2.0 g/kg) will prescribed for home enteral nutrition
Usual dose of protein (1.5 g/kg) will prescribed for home enteral nutrition
Muscle mass changes
Changes of muscle mass in kilograms measured by impedance bioelectric
Time frame: From randomization to 6 months
Swallow recovery
Time to safe swallowing diagnosed by fibroendoscopy evaluation of swallowing (FEES) and measured in months
Time frame: From randomization to 6 months
Duration of enteral nutrition indication
Time from discharge to feeding tube removal
Time frame: From randomization to 6 months
Feeding tube complications
Number of feeding tube infections, dysfunctions and oclusions during study period
Time frame: From randomization to 6 months
Muscle functionality changes
Changes in functionality measured by medical research council scale in a scale of 0-60 points
Time frame: From randomization to 6 months
Handgrip strenght changes
Changes in functionality assessed by handgrip strenght in kilogramos using a digital dynamometer
Time frame: From randomization to 6 months
Frailty complications
Number of falls and fractures during study period
Time frame: From randomization to 6 months
Hospital readmissions associated to dysphagia complications
Number of hospital readmissions assocciated to feeding tube infections, dysfunctions and oclusions during study period
Time frame: From randomization to 6 months
6-month mortality
All-cause mortality during study period
Time frame: From randomization to 6 months
Aspiration pneumonia incidence
Number of hospital readmissions due to aspiration pneumonia
Time frame: From randomization to 6 months
Plan to share: No
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National Institute of Respiratory Diseases, Mexico