Nutritional therapy for patients with swallowing difficulties after extubation
Official title: Swallowing and Nutritional Therapy and Its Impact on Body Composition and Clinical Outcomes in Patients With Post-extubation Dysphagia
Run by National Institute of Respiratory Diseases, Mexico · NCT06511284 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | National Institute of Respiratory Diseases, Mexico Government |
| Locations | 1 site (Mexico City) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | December 30, 2026 |
| Study ends | December 1, 2027 |
| Registry record updated | July 19, 2024 |
| Trial ID | NCT06511284 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients who required invasive mechanical ventilation and have been diagnosed with post-extubation dysphagia, discharged with a feeding tube.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the specific approach of this study may be novel, similar studies focusing on nutritional interventions for dysphagia have shown promising results.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How surgery for obstructive sleep apnea affects swallowing and oral function
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This trial tests whether pairing a noninvasive taVNS treatment with oral sensorimotor training helps infants in NICUs swallow better and feed more safely.
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This study tests whether digital tongue-pressure biofeedback training helps people with swallowing difficulties after stroke.
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Masseter and Thigh Muscle Ultrasound to Predict Dysphagia and Sarcopenia in Critically Ill Adults
This study tests whether measuring the masseter muscle with ultrasound can help identify dysphagia in adults after critical illness and extubation, alongside evaluation of sarcopenia.
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Impact of Patient Position on EndoFLIP Measurements in Kids and Young Adults
This study tests whether EndoFLIP measurements differ when patients are in the supine versus left-side position during the procedure.
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Effects of CTAR and a Swallowing Pressure Ball in Older Stroke Adults
This study tests whether home-based CTAR exercises plus a swallowing pressure ball can improve swallowing function and eating-related quality of life for older adults who had a stroke and have dysphagia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.