Dysphagia
Conditions
Keywords
enteral nutrition, nutritional assessment, nutritional therapy, Deglutition Disorders, rehabilitation
Brief summary
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.
Interventions
OTHERHigh protein dose
High dose of protein (2.0 g/kg) will prescribed for home enteral nutrition
OTHERUsual protein dose
Usual dose of protein (1.5 g/kg) will prescribed for home enteral nutrition
Sponsors
National Institute of Respiratory Diseases, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Amounts of protein was not revealed for participants
Intervention model description
Randomized Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who required invasive mechanical ventilation during their hospital stay with a diagnosis of post-extubation dysphagia diagnosed by fibroendoscopy evaluation of swallowing (FEES). * Patients who discharged with a feeding tube. * Patients with signed informed consent.
Exclusion criteria
* Patients with pre-existing dysphagia, or with neurological conditions that can cause dysphagia (e.g. multiple sclerosis, Parkinson's disease, Alzheimer's, myasthenia gravis). * Patients with chronic kidney disease, defined as a glomerular filtration rate \<60 ml/min. * Patients discharged with a terminal condition and/or life expectancy of less than 3 months. * Diagnosis of HIV, upon receiving clinical follow-up by the team of specialists.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle mass changes | From randomization to 6 months | Changes of muscle mass in kilograms measured by impedance bioelectric |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of enteral nutrition indication | From randomization to 6 months | Time from discharge to feeding tube removal |
| Feeding tube complications | From randomization to 6 months | Number of feeding tube infections, dysfunctions and oclusions during study period |
| Muscle functionality changes | From randomization to 6 months | Changes in functionality measured by medical research council scale in a scale of 0-60 points |
| Handgrip strenght changes | From randomization to 6 months | Changes in functionality assessed by handgrip strenght in kilogramos using a digital dynamometer |
| Swallow recovery | From randomization to 6 months | Time to safe swallowing diagnosed by fibroendoscopy evaluation of swallowing (FEES) and measured in months |
| Hospital readmissions associated to dysphagia complications | From randomization to 6 months | Number of hospital readmissions assocciated to feeding tube infections, dysfunctions and oclusions during study period |
| 6-month mortality | From randomization to 6 months | All-cause mortality during study period |
| Aspiration pneumonia incidence | From randomization to 6 months | Number of hospital readmissions due to aspiration pneumonia |
| Frailty complications | From randomization to 6 months | Number of falls and fractures during study period |
Countries
Mexico
Contacts
Primary ContactIvan A Osuna-Padilla, PhD
Backup ContactAlan Garcia-Grimaldo, MSc
Outcome results
None listed