Nutritional therapy for patients with swallowing difficulties after extubation
Swallowing and Nutritional Therapy and Its Impact on Body Composition and Clinical Outcomes in Patients With Post-extubation Dysphagia
This study tests if giving patients with swallowing difficulties after being on a breathing machine a higher protein diet can help them recover better and avoid complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Respiratory Diseases, Mexico Government |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT06511284 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of two different protein doses on muscle mass and clinical outcomes in patients experiencing post-extubation dysphagia. Participants will receive either a high protein dose or a usual protein dose while being monitored for improvements in swallowing safety, feeding tube removal, hospital readmissions, and other health complications over a six-month period post-discharge. The study aims to determine how nutritional therapy can enhance recovery and overall functionality in these patients.
Who should consider this trial
Good fit: Ideal candidates are patients who required invasive mechanical ventilation and have been diagnosed with post-extubation dysphagia, discharged with a feeding tube.
Not a fit: Patients with pre-existing dysphagia or neurological conditions causing dysphagia, as well as those with chronic kidney disease or terminal conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery and quality of life for patients with post-extubation dysphagia.
How similar studies have performed: While the specific approach of this study may be novel, similar studies focusing on nutritional interventions for dysphagia have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mexico City
- National Institute of Respiratory Diseases — Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Ivan A Osuna-Padilla, PhD — Instituto Nacional de Enfermedades Respiratorias
- Study coordinator: Ivan A Osuna-Padilla, PhD
- Email: ivan.osuna@iner.gob.mx
- Phone: +5216671035806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.