Nutritional Therapy in Patients With Post-extubation Dysphagia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High protein dose, Usual protein dose.
- Who it may be relevant to
- Registry conditions: Dysphagia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Swallowing and Nutritional Therapy and Its Impact on Body Composition and Clinical Outcomes in Patients With Post-extubation Dysphagia
Overview
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
- Other High protein dose
High dose of protein (2.0 g/kg) will prescribed for home enteral nutrition - Other Usual protein dose
Usual dose of protein (1.5 g/kg) will prescribed for home enteral nutrition
Primary outcome measures
- Muscle mass changes [Time frame: From randomization to 6 months]
Secondary outcome measures (9)
- Swallow recovery [Time frame: From randomization to 6 months]
- Duration of enteral nutrition indication [Time frame: From randomization to 6 months]
- Feeding tube complications [Time frame: From randomization to 6 months]
- Muscle functionality changes [Time frame: From randomization to 6 months]
- Handgrip strenght changes [Time frame: From randomization to 6 months]
- Frailty complications [Time frame: From randomization to 6 months]
- Hospital readmissions associated to dysphagia complications [Time frame: From randomization to 6 months]
- 6-month mortality [Time frame: From randomization to 6 months]
- Aspiration pneumonia incidence [Time frame: From randomization to 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Mexico · 1 center
- National Institute of Respiratory Diseases — Mexico City
Identifiers
NCT: NCT06511284 · C32-24