Swallowing and Nutritional Therapy and Its Impact on Body Composition and Clinical Outcomes in Patients With Post-extubation Dysphagia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Muscle mass changes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Amounts of protein was not revealed for participants
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
High protein group
100% of the energy requirements measured by indirect calorimetry (IC) or estimated, and a protein intake of 2.0 g/kg, will be prescribed
Intervention: High protein dose (Other)
Usual protein group
100% of the energy requirements measured by IC or estimated, and a protein intake of 1.5 g/kg, will be prescribed.
Intervention: Usual protein dose (Other)
Outcomes
Primary Outcomes
Muscle mass changes
Time Frame: From randomization to 6 months
Changes of muscle mass in kilograms measured by impedance bioelectric
Secondary Outcomes
- Swallow recovery(From randomization to 6 months)
- Feeding tube complications(From randomization to 6 months)
- Muscle functionality changes(From randomization to 6 months)
- Duration of enteral nutrition indication(From randomization to 6 months)
- Frailty complications(From randomization to 6 months)
- 6-month mortality(From randomization to 6 months)
- Handgrip strenght changes(From randomization to 6 months)
- Aspiration pneumonia incidence(From randomization to 6 months)
- Hospital readmissions associated to dysphagia complications(From randomization to 6 months)
Investigators
Ivan Armando Osuna Padilla
Clinical Nutrition Manager
National Institute of Respiratory Diseases, Mexico