Nutritional Therapy in Patients With Post-extubation Dysphagia

Not Applicable

Recruiting

• Conditions: Dysphagia
• Interventions: Other: High protein dose; Other: Usual protein dose

• Registration Number: NCT06511284
• Lead Sponsor: National Institute of Respiratory Diseases, Mexico

Brief 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, functionality, number of falls, fractures and mortality) at 6 months after hospital discharge in patients with enteral nutrition due to post-extubation dysphagia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-01
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Study First Posted: 2024-07-19
• Last Update Posted: 2024-07-19
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High protein group	High protein dose	100% 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	Usual protein dose	100% of the energy requirements measured by IC or estimated, and a protein intake of 1.5 g/kg, will be prescribed.

Primary Outcome Measures

Name	Time	Method
Muscle mass changes	From randomization to 6 months	Changes of muscle mass in kilograms measured by impedance bioelectric

Secondary Outcome Measures

Name	Time	Method
Swallow recovery	From randomization to 6 months	Time to safe swallowing diagnosed by fibroendoscopy evaluation of swallowing (FEES) and measured in months
Feeding tube complications	From randomization to 6 months	Number of feeding tube infections, dysfunctions and oclusions during study period
Muscle functionality changes	From randomization to 6 months	Changes in functionality measured by medical research council scale in a scale of 0-60 points
Duration of enteral nutrition indication	From randomization to 6 months	Time from discharge to feeding tube removal
Frailty complications	From randomization to 6 months	Number of falls and fractures during study period
6-month mortality	From randomization to 6 months	All-cause mortality during study period
Handgrip strenght changes	From randomization to 6 months	Changes in functionality assessed by handgrip strenght in kilogramos using a digital dynamometer
Aspiration pneumonia incidence	From randomization to 6 months	Number of hospital readmissions due to aspiration pneumonia
Hospital readmissions associated to dysphagia complications	From randomization to 6 months	Number of hospital readmissions assocciated to feeding tube infections, dysfunctions and oclusions during study period

Trial Locations

Locations (1)

National Institute of Respiratory Diseases; 🇲🇽 Mexico City, Mexico