An observational study in Dysphagia and Sarcopenia, sponsored by Sara Casanova Prieto. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Sara Casanova Prieto · Observational
Among 39 studies in Deglutition Disorders with a site in Spain — 11 open to participants now, 11 under way, none of them phase 3. Deglutition Disorders · Spain.
Among the 39 studies in Deglutition Disorders with a site in Spain, this one is one of 4 that started in 2026, is one of 8 observational ones, reaches primary completion later than 7 of the 10 other live ones, and was the 38th registered.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 323 is above the median of 84 across 249 observational studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →11 of the 39 studies in Deglutition Disorders with a site in Spain are open now, in 8 countries. Each count lists the studies.
Of the 137 Deglutition Disorders studies recruiting now, 74 (54%) set no upper age limit and 27 (20%) stop at 75 or younger; 15 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →39 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 4 started in 2026.
Median enrollment 62 across the 31 interventional studies, 90 across the 8 observational. Of the 23 that completed or were terminated, 2 (9%) have results posted.
8 of 39 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Sara Casanova Prieto as lead sponsor.
Sara Casanova Prieto has 1 study filed under Deglutition Disorders — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 39 studies in Deglutition Disorders with a site in Spain, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
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 months
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.
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.
Association of Dysphagia and Sarcopenia With Clinical Outcomes
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.
Time frame: From ICU admission through 6 months after ICU discharge
Plan to share: No — Individual participant data (IPD) will not be publicly shared due to participant confidentiality and data protection requirements. Aggregated and anonymized study results will be reported in scientific publications and presentations.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2027, 22 months after the start.
Of 117 non-industry observational studies under Deglutition Disorders, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 52. This study's planned 22 months is below that.
Counting every sponsor, half of 120 studies reached it within 25 months; a quarter within 11 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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