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Diagnostic Accuracy of Masseter and Rectus Femoris Muscle Ultrasound for the Diagnosis of Dysphagia and Sarcopenia in Critically Ill Patients

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital General Universitario Gregorio Marañón
RECRUITING
Madrid
Contact Information
Primary
SARA CASANOVA PRIETO, MD
sara.casanova@salud.madrid.org
+34665286063
Time Frame
Start Date: 2026-02-03
Estimated Completion Date: 2028-08
Participants
Target number of participants: 323
Treatments
Extubated Critically Ill Patients
Adult critically ill patients who received invasive mechanical ventilation for at least 48 hours and are assessed after extubation. Participants undergo masseter and rectus femoris muscle ultrasound and dysphagia assessment using the modified Volume-Viscosity Swallow Test (MECVVm) according to the study protocol.
Tracheostomized Critically Ill Patients
Adult critically ill patients with a tracheostomy who meet the study eligibility criteria. Participants undergo masseter and rectus femoris muscle ultrasound and dysphagia assessment using the modified Volume-Viscosity Swallow Test (MECVVm) according to the study protocol.
Related Therapeutic Areas
Sponsors
Collaborators: Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
Leads: Sara Casanova Prieto

This content was sourced from clinicaltrials.gov