Dysphagia, Sarcopenia
Conditions
Keywords
Post-extubation dysphagia, Masseter muscle, Rectus femoris muscle, Muscle ultrasound, Critical illness, Intensive care unit, MECV-V, Muscle mass
Brief summary
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.
Interventions
None listed
Sponsors
Sara Casanova Prieto
Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association Between Masseter Muscle Thickness and Dysphagia | At the time of dysphagia assessment: 6 to 36 hours after extubation in extubated patients, or once tracheostomized patients tolerate at least 6 hours/day of spontaneous breathing without mechanical ventilation. | Maximum masseter muscle thickness will be measured by ultrasound and its association with the presence of dysphagia will be assessed. Dysphagia will be determined using the modified Volume-Viscosity Swallow Test (MECVVm). The association will be evaluated separately in extubated critically ill patients and critically ill patients with a tracheostomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Dysphagia in Critically Ill Patients | At the time of dysphagia assessment: 6 to 36 hours after extubation in extubated patients, or once tracheostomized patients tolerate at least 6 hours/day of spontaneous breathing without mechanical ventilation. | The proportion of participants with dysphagia will be determined using the modified Volume-Viscosity Swallow Test (MECVVm). Dysphagia occurrence will be assessed separately in extubated critically ill patients and critically ill patients with a tracheostomy. |
| Risk Factors Associated With Dysphagia | From ICU admission to the time of dysphagia assessment, up to 4 months | Demographic, clinical, severity-of-illness, mechanical ventilation, airway management, neurological, nutritional, and functional variables collected during the ICU stay will be analyzed to identify factors independently associated with dysphagia, as determined by the modified Volume-Viscosity Swallow Test (MECVVm), in extubated and tracheostomized critically ill patients. |
| Ability of Masseter Muscle Ultrasound to Identify Risk of Sarcopenia | At 48 hours after invasive mechanical ventilation and at dysphagia assessment (6-36 hours after extubation or, in tracheostomized patients, when tolerating at least 6 hours/day without mechanical ventilation), up to 4 months after ICU admission. | The ability of masseter muscle ultrasound to identify critically ill patients at risk of sarcopenia will be evaluated by comparing masseter muscle thickness with ultrasound measurements of the rectus femoris muscle. |
| Ultrasound Cut-off Values for Dysphagia and Sarcopenia | At dysphagia assessment, up to 4 months after ICU admission. | Receiver operating characteristic (ROC) curve analysis will be used to determine optimal cut-off values for masseter and rectus femoris muscle thickness for discriminating dysphagia and sarcopenia in critically ill patients. Diagnostic performance will be assessed using sensitivity, specificity, positive and negative predictive values, and the Youden index. |
| Association of Dysphagia and Sarcopenia With Clinical Outcomes | From ICU admission through 6 months after ICU discharge | The association between dysphagia and sarcopenia, as assessed by the study procedures, and relevant clinical outcomes will be evaluated. Clinical outcomes include ICU length of stay, nutritional complications, and mortality. |
Countries
Spain
Contacts
CONTACTSARA CASANOVA PRIETO, MD
Outcome results
None listed