Nutritional Therapy in Patients With Post-extubation Dysphagia
ConditionDysphagia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Institute of Respiratory Diseases, Mexico
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
High protein dose
Other interventionHigh dose of protein (2.0 g/kg) will prescribed for home enteral nutrition
Usual protein dose
Other interventionUsual dose of protein (1.5 g/kg) will prescribed for home enteral nutrition
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: High protein groupExperimental treatment 1 intervention
Group B: Usual protein groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Muscle mass changes
Changes of muscle mass in kilograms measured by impedance bioelectric
Time frame
From randomization to 6 monthsSecondary outcomes
1
Swallow recovery
Time to safe swallowing diagnosed by fibroendoscopy evaluation of swallowing (FEES) and measured in months
Time frame
From randomization to 6 months2
Duration of enteral nutrition indication
Time from discharge to feeding tube removal
Time frame
From randomization to 6 months3
Feeding tube complications
Number of feeding tube infections, dysfunctions and oclusions during study period
Time frame
From randomization to 6 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov