Nutritional Therapy in Patients With Post-extubation Dysphagia

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.

Study Overview

• Status: Recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Other: High protein dose; Other: Usual protein dose

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivan A Osuna-Padilla, PhD; Phone Number: +5216671035806; Email: ivan.osuna@iner.gob.mx
• Study Contact Backup: Name: Alan Garcia-Grimaldo, MSc; Email: agarciag1716@gmail.com

Study Locations

• Mexico
  • Mexico City, Mexico, 14080
    • Recruiting
    • National Institute of Respiratory Diseases
    • Contact: Ana L Gomez-Rodriguez, MSc; Phone Number: +52 1 55 2573 2734; Email: grolucia@yahoo.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: High protein dose; High dose of protein (2.0 g/kg) will prescribed for home enteral nutrition
Other: 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.	Other: Usual protein dose; Usual dose of protein (1.5 g/kg) will prescribed for home enteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle mass changes	Changes of muscle mass in kilograms measured by impedance bioelectric	From randomization to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Institute of Respiratory Diseases, Mexico
• Investigators: Principal Investigator: Ivan A Osuna-Padilla, PhD, National Institute of Respiratory Diseases

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; enteral nutrition; Deglutition Disorders; nutritional assessment; nutritional therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: C32-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No