Nutritional Therapy in Patients With Post-extubation Dysphagia

National Institute of Respiratory Diseases, Mexico

Status: Enrolling

Conditions: Dysphagia

Treatments: Other: Usual protein dose; Other: High protein dose

Study type: Interventional

Funder types: Other

Identifiers

NCT06511284

C32-24

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

High protein group

Experimental group

Description:

100% of the energy requirements measured by indirect calorimetry (IC) or estimated, and a protein intake of 2.0 g/kg, will be prescribed

Treatment:

Other: High protein dose

Usual protein group

Other group

Description:

100% of the energy requirements measured by IC or estimated, and a protein intake of 1.5 g/kg, will be prescribed.

Treatment:

Other: Usual protein dose