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NCT Number: NCT07787312

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

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.

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Key information

Conditions

Dysphagia Atrophy Critical Illness Deglutition Disorders Digestive System Diseases Disease Attributes Esophageal Diseases Gastrointestinal Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location status: Recruiting

Location contact

SARA CASANOVA PRIETO, MD

CONTACT

[email protected]

+34665286063

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Association Between Masseter Muscle Thickness and Dysphagia

    Time frame: 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 outcomes

  1. Occurrence of Dysphagia in Critically Ill Patients

    Time frame: 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.

  2. Risk Factors Associated With Dysphagia

    Time frame: 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.

  3. Ability of Masseter Muscle Ultrasound to Identify Risk of Sarcopenia

    Time frame: 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.

  4. Ultrasound Cut-off Values for Dysphagia and Sarcopenia

    Time frame: 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.

  5. Association of Dysphagia and Sarcopenia With Clinical Outcomes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

SARA CASANOVA PRIETO, MD

CONTACT

[email protected]

+34665286063

Sponsors and collaborators

Lead sponsor

Sara Casanova Prieto

Other

Collaborators

  • Fundación para la Investigación Biomédica del Hospital Gregorio Maranon

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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