[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653575":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":37,"armGroups":38,"interventions":33,"overallOfficials":33,"centralContacts":45,"locations":51,"responsibleParty":67,"collaborators":71,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":33,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":33,"enrollmentInfo":83,"targetDuration":33,"studyType":86,"phases":33,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":54,"whyStopped":33,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Hospital General Universitario Gregorio Marañon","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"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.","At the time of dysphagia assessment: 6 to 36 hours after extubation in extubated patients, or once tracheostomized patients tolerate at least 6 hours\u002Fday of spontaneous breathing without mechanical ventilation.",[14,17,21,25,29],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":20},"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.","From ICU admission to the time of dysphagia assessment, up to 4 months",{"measure":22,"description":23,"timeFrame":24},"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.","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\u002Fday without mechanical ventilation), up to 4 months after ICU admission.",{"measure":26,"description":27,"timeFrame":28},"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.","At dysphagia assessment, up to 4 months after ICU admission.",{"measure":30,"description":31,"timeFrame":32},"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.","From ICU admission through 6 months after ICU discharge",null,{"allocation":33,"interventionModel":33,"interventionModelDescription":33,"primaryPurpose":33,"observationalModel":35,"timePerspective":36,"maskingInfo":33},"COHORT","PROSPECTIVE","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.",[39,42],{"label":40,"type":33,"description":41,"interventionNames":33},"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.",{"label":43,"type":33,"description":44,"interventionNames":33},"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.",[46],{"name":47,"role":48,"phone":49,"phoneExt":33,"email":50},"SARA CASANOVA PRIETO, MD","CONTACT","+34665286063","sara.casanova@salud.madrid.org",[52],{"facility":53,"status":54,"city":55,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Hospital General Universitario Gregorio Marañón","RECRUITING","Madrid","28007","Spain","ES",{"type":60,"coordinates":61},"Point",[62,63],-3.70256,40.4165,{"lat":63,"lon":62},[66],{"name":47,"role":48,"phone":49,"phoneExt":33,"email":50},{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","Sara Casanova Prieto","Principal Investigator",[72],{"name":73,"class":6},"Fundación para la Investigación Biomédica del Hospital Gregorio Maranon","100653575","masseter-and-rectus-femoris-ultrasound-for-dysphagia-and-sarcopenia-in-critically-ill-patients-100653575",false,"NCT07787312","Masseter and Rectus Femoris Ultrasound for Dysphagia and Sarcopenia in Critically Ill Patients","Diagnostic Accuracy of Masseter and Rectus Femoris Muscle Ultrasound for the Diagnosis of Dysphagia and Sarcopenia in Critically Ill Patients","Inclusion Criteria:\n\n* Age ≥18 years.\n* Critically ill patients requiring invasive mechanical ventilation for \\>48 hours.\n* Extubated patients: extubation 6-36 hours before study assessment.\n* Tracheostomized patients: surgical or percutaneous tracheostomy considered clinically suitable to initiate oral feeding, tolerating spontaneous breathing without mechanical ventilation for at least 6 hours\u002Fday, and negative cuff-leak test.\n* Awake and cooperative, with effective cough and ability to manage oral secretions.\n* Written informed consent obtained.\n\nExclusion Criteria:\n\n* Documented pre-existing oropharyngeal dysphagia.\n* Inability to undergo study assessment within 36 hours after extubation.\n* In tracheostomized patients, positive cuff-leak test before study assessment.","ALL","18 Years",{"count":84,"type":85},323,"ESTIMATED","OBSERVATIONAL","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.\n\nThis 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.\n\nThe 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.",[89,90],"Dysphagia","Sarcopenia",[92,93,94,95,96,97,98,99],"Post-extubation dysphagia","Masseter muscle","Rectus femoris muscle","Muscle ultrasound","Critical illness","Intensive care unit","MECV-V","Muscle mass","2026-08-21",{"date":102,"type":103},"2026-08-26","ACTUAL",{"date":105,"type":103},"2026-02-03",{"date":107,"type":85},"2028-08",{"name":69,"class":6},1]