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Masseter and Rectus Femoris Ultrasound for Dysphagia and Sarcopenia in Critically Ill Patients

Masseter and Rectus Femoris Ultrasound for Dysphagia and Sarcopenia in Critically Ill Patients

Recruiting
18 years and older
All
Phase N/A

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Overview

Dysphagia and sarcopenia are common complications in critically ill patients and are associated with increased morbidity, prolonged hospitalization, nutritional complications, and poorer clinical outcomes. Muscle ultrasound is a non-invasive bedside technique that may provide objective information on muscle mass and help identify patients at increased risk of these conditions.

This single-center observational diagnostic accuracy study will evaluate the association between masseter muscle thickness measured by ultrasound and the presence of dysphagia in critically ill adult patients after extubation and in patients with a tracheostomy. Dysphagia will be assessed using the Modified Volume-Viscosity Swallow Test (MECVVm). Ultrasound measurements of the masseter and rectus femoris muscles will also be evaluated to investigate their relationship with sarcopenia and relevant clinical outcomes.

The study aims to determine the diagnostic performance of masseter muscle ultrasound for identifying dysphagia, establish ultrasound cut-off values associated with dysphagia and sarcopenia, and explore whether these measurements may facilitate early risk stratification in critically ill patients.

Eligibility

Inclusion Criteria:

  • Age ≥18 years.
  • Critically ill patients requiring invasive mechanical ventilation for \>48 hours.
  • Extubated patients: extubation 6-36 hours before study assessment.
  • Tracheostomized patients: surgical or percutaneous tracheostomy considered clinically suitable to initiate oral feeding, tolerating spontaneous breathing without mechanical ventilation for at least 6 hours/day, and negative cuff-leak test.
  • Awake and cooperative, with effective cough and ability to manage oral secretions.
  • Written informed consent obtained.

Exclusion Criteria:

  • Documented pre-existing oropharyngeal dysphagia.
  • Inability to undergo study assessment within 36 hours after extubation.
  • In tracheostomized patients, positive cuff-leak test before study assessment.

Study details
    Dysphagia
    Sarcopenia

NCT07787312

Sara Casanova Prieto

29 August 2026

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