Nutritional Therapy in Patients With Post-extubation Dysphagia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2027-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Clinical Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Amounts of protein was not revealed for participants

Study Groups

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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

Group Type EXPERIMENTAL

High protein dose

Intervention Type OTHER

High dose of protein (2.0 g/kg) will prescribed for home enteral nutrition

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.

Group Type OTHER

Usual protein dose

Intervention Type OTHER

Usual dose of protein (1.5 g/kg) will prescribed for home enteral nutrition

Interventions

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High protein dose

High dose of protein (2.0 g/kg) will prescribed for home enteral nutrition

Intervention Type OTHER

Usual protein dose

Usual dose of protein (1.5 g/kg) will prescribed for home enteral nutrition

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No