DysphagiaNCT06511284
Nutritional Therapy in Patients With Post-extubation Dysphagia
A study testing High protein dose and Usual protein dose in people with Dysphagia, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- High protein dose and Usual protein dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alan Garcia-Grimaldo, MSc contact
Mexico1 site, 1 recruiting
- Recruiting
National Institute of Respiratory Diseases
Mexico City, 14080
Ana L Gomez-Rodriguez, MSc, +52 1 55 2573 2734, grolucia@yahoo.es
About this study
Official title: Swallowing and Nutritional Therapy and Its Impact on Body Composition and Clinical Outcomes 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.
- Conditions
- Dysphagia
- Being tested
- High protein dose, Usual protein dose
- Keywords
- enteral nutrition, nutritional assessment, nutritional therapy, Deglutition Disorders, rehabilitation
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein doseOther
High dose of protein (2.0 g/kg) will prescribed for home enteral nutrition
Usual protein doseOther
Usual dose of protein (1.5 g/kg) will prescribed for home enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| High protein group | Experimental | 100% of the energy requirements measured by indirect calorimetry (IC) or estimated, and a protein intake of 2.0 g/kg, will be prescribed Receives: Other: High protein dose |
| Usual protein group | Other | 100% of the energy requirements measured by IC or estimated, and a protein intake of 1.5 g/kg, will be prescribed. Receives: Other: Usual protein dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass changes
Changes of muscle mass in kilograms measured by impedance bioelectric
Measured: From randomization to 6 months
Secondary outcomes (9)
Swallow recovery
Time to safe swallowing diagnosed by fibroendoscopy evaluation of swallowing (FEES) and measured in months
Measured: From randomization to 6 months
Duration of enteral nutrition indication
Time from discharge to feeding tube removal
Measured: From randomization to 6 months
Feeding tube complications
Number of feeding tube infections, dysfunctions and oclusions during study period
Measured: From randomization to 6 months
Muscle functionality changes
Changes in functionality measured by medical research council scale in a scale of 0-60 points
Measured: From randomization to 6 months
Handgrip strenght changes
Changes in functionality assessed by handgrip strenght in kilogramos using a digital dynamometer
Measured: From randomization to 6 months
Frailty complications
Number of falls and fractures during study period
Measured: From randomization to 6 months
Hospital readmissions associated to dysphagia complications
Number of hospital readmissions assocciated to feeding tube infections, dysfunctions and oclusions during study period
Measured: From randomization to 6 months
6-month mortality
All-cause mortality during study period
Measured: From randomization to 6 months
Aspiration pneumonia incidence
Number of hospital readmissions due to aspiration pneumonia
Measured: From randomization to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Jul 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Respiratory Diseases, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ivan Armando Osuna Padilla, National Institute of Respiratory Diseases, Mexico
- Investigators
- Ivan A Osuna-Padilla, PhD, Principal investigator, Instituto Nacional de Enfermedades Respiratorias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511284
- Sponsor's protocol ID
- C32-24
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swallowing and Nutritional Therapy and Its Impact on Body Composition and Clinical Outcomes in Patients With Post-extubation Dysphagia
- ClinicalTrials.gov ID
- NCT06511284
- Acronym / sponsor ID
- C32-24
- Conditions
- Dysphagia
- Keywords
- enteral nutrition, nutritional assessment, nutritional therapy, Deglutition Disorders, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- National Institute of Respiratory Diseases, MexicoOther government
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| High protein group | Experimental | Other: High protein dose100% of the energy requirements measured by indirect calorimetry (IC) or estimated, and a protein intake of 2.0 g/kg, will be prescribed |
| Usual protein group | Other | Other: Usual protein dose100% of the energy requirements measured by IC or estimated, and a protein intake of 1.5 g/kg, will be prescribed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High protein doseHigh dose of protein (2.0 g/kg) will prescribed for home enteral nutrition | Other | High protein group |
| Usual protein doseUsual dose of protein (1.5 g/kg) will prescribed for home enteral nutrition | Other | Usual protein group |
Primary outcome
Muscle mass changes
Time frame: From randomization to 6 months
Changes of muscle mass in kilograms measured by impedance bioelectric
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: No
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Dysphagia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan Garcia-Grimaldo, MSc contact
Ivan A Osuna-Padilla, PhD principal investigator
Instituto Nacional de Enfermedades Respiratorias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein dose and Usual protein dose in people with Dysphagia, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan A Osuna-Padilla, PhD (+5216671035806, ivan.osuna@iner.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass changes (time frame: From randomization to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.