Masseter and Rectus Femoris Ultrasound for Dysphagia and Sarcopenia in Critically Ill Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSara Casanova Prieto
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adult critically ill patients admitted to the Intensive Care Unit of Hospital General Universitario Gregorio Marañón who require invasive mechanical ventilation for more than 48 hours. The study population includes patients assessed after extubation and patients with a tracheostomy who meet the predefined eligibility criteria and are clinically suitable for dysphagia assessment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
323 Participants
are grouped into 2 trial groupsGroup A: Extubated Critically Ill Patients
Group B: Tracheostomized Critically Ill Patients
Trial outcomes
Primary outcomes
1
Association Between Masseter Muscle Thickness and Dysphagia
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.
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.Secondary outcomes
1
Occurrence of Dysphagia in Critically Ill Patients
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.
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.2
Risk Factors Associated With Dysphagia
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.
Time frame
From ICU admission to the time of dysphagia assessment, up to 4 months3
Ability of Masseter Muscle Ultrasound to Identify Risk of Sarcopenia
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.
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.4
Ultrasound Cut-off Values for Dysphagia and Sarcopenia
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.
Time frame
At dysphagia assessment, up to 4 months after ICU admission.Sponsors and contacts
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Sara Casanova Prieto
Lead sponsor
Hospital General Universitario Gregorio Marañon
Sponsor institution
Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
Collaborator
Source ClinicalTrials.gov