National Institute of Respiratory Diseases
Mexico City, 14080, Mexico
Location status: Recruiting
Recruiting
NCT Number: NCT06511284
Nutritional Therapy in Patients With Post-extubation Dysphagia
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
High protein dose
OtherHigh dose of protein (2.0 g/kg) will prescribed for home enteral nutrition
Usual protein dose
OtherUsual dose of protein (1.5 g/kg) will prescribed for home enteral nutrition
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
Time frame: From randomization to 6 months
Time to safe swallowing diagnosed by fibroendoscopy evaluation of swallowing (FEES) and measured in months
-
Duration of enteral nutrition indication
Time frame: From randomization to 6 months
Time from discharge to feeding tube removal
-
Feeding tube complications
Time frame: From randomization to 6 months
Number of feeding tube infections, dysfunctions and oclusions during study period
-
Muscle functionality changes
Time frame: From randomization to 6 months
Changes in functionality measured by medical research council scale in a scale of 0-60 points
-
Handgrip strenght changes
Time frame: From randomization to 6 months
Changes in functionality assessed by handgrip strenght in kilogramos using a digital dynamometer
-
Frailty complications
Time frame: From randomization to 6 months
Number of falls and fractures during study period
-
Hospital readmissions associated to dysphagia complications
Time frame: From randomization to 6 months
Number of hospital readmissions assocciated to feeding tube infections, dysfunctions and oclusions during study period
-
6-month mortality
Time frame: From randomization to 6 months
All-cause mortality during study period
-
Aspiration pneumonia incidence
Time frame: From randomization to 6 months
Number of hospital readmissions due to aspiration pneumonia
Study contacts
Contact information is provided by the study sponsor or research team.
Alan Garcia-Grimaldo, MSc
CONTACT
Ivan A Osuna-Padilla, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
National Institute of Respiratory Diseases, Mexico
Other Gov
Registry information
Official study title
Swallowing and Nutritional Therapy and Its Impact on Body Composition and Clinical Outcomes in Patients With Post-extubation Dysphagia
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Jul 19, 2024
- Registry last updated
- Jul 19, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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