[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544473":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":27,"locations":10,"responsibleParty":33,"collaborators":37,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":10,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":53,"studyType":54,"phases":10,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":66,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":10},{"fullName":5,"class":6},"Universidad Europea de Madrid","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"group control",null,"undeveloped dysphagia",[13],"Diagnostic Test: Ultrasound",{"label":15,"type":10,"description":16,"interventionNames":17},"Group cohort","Developed dysphagia",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","Ultrasound","The physical function variables will be analyzed through the Medical Research Council (MRC) and Functional Status Score (FSS), as well as swallowing function variables through the Volume-Viscosity Swallow (VVS-T) and Functional Oral Intake Scale scales. (FOIS) and Gugging Swallowing Screen (GUSS). The ecographic measurements will be made of the thickness and echogenicity of the submental and tonue muscles, as well as hyolaryngeal kinematics. These measurements will be performed 48 hours from the start of the orotracheal intubation episode, 7 days and 14 days of mechanical ventilation. To enable the correlation of clinical and ultrasound variables, one more independent measurement will be performed within the first 24 hours after authorization of oral tolerance in the patient.",[15,9],[25,26],"Physical function","Swallowing function",[28],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Teresa E Fernandez-Pardo, Msc","CONTACT","0034650193112","teresa.fernandez@universidadeuropea.es",{"type":34,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Teresa Fernandez Pardo","Principal investigator",[38],{"name":39,"class":6},"Hospital Universitario Ramon y Cajal","100544473","ultrasound-study-of-the-submentonian-musculature-and-its-relationship-in-dysphagia-100544473",false,"NCT06369337","Ultrasound Study of the Submentonian Musculature and Its Relationship in Dysphagia","Ultrasound Study of the Submentonian Musculature and Its Relationship in the Development of Dysphagia After Invasive Mechanical Ventilation: a Single-center Cohort Study","Inclusion Criteria:\n\n* • Subjects \\>18 years old.\n\n  * Having received an episode of orotracheal intubation for \\>48h\n\nExclusion Criteria:\n\n* • Congenital or acquired conditions of the Central Nervous System (CNS) such as stroke, traumatic brain injury, Parkinson's, multiple sclerosis, amyotrophic lateral sclerosis (ALS) or any other condition that may bias the attribution of dysphagia to factors other than exclusively clinical ones.\n\n  * Involvement of the cranial nerves or the Peripheral Nervous System (PNS) as well as diseases of the neuromuscular junction such as Myasthenia Gravis or any other condition that may bias the attribution of dysphagia to other factors that are not exclusively clinical.\n  * Neck morphology incompatible with exploration through ultrasound procedures.\n  * Secondary musculoskeletal injuries, including vertebral fractures, unstable extremity fractures or any condition that requires absolute bed rest as prescribed by a doctor.\n  * Malignant tumor lesions or previous head and\u002For neck surgeries.\n  * Medical-surgical history due to pathology of the larynx, oropharynx and\u002For esophagus.\n  * Diagnosis of dysphagia or swallowing disorders prior to the intubation episode with IMV.\n  * Patients unable to eat orally, at least partially.\n  * Known prior cognitive impairment upon admission to the ICU.","ALL","18 Years","65 Years",{"count":51,"type":52},150,"ESTIMATED","1 Year","OBSERVATIONAL","Acquired dysphagia is one of the most frequent complications suffered by patients in intensive care units (ICU) after orotracheal extubation. Ultrasound has proven to be a useful method in the morphological and kinematic exploration of the main swallowing structures. AIM: to evaluate, through ultrasound procedures, the evolution of the morphology of the tongue and muscles of the floor of the mouth and the hyolaryngeal kinematics in patients intubated \\>48h and to correlate these measurements with the possible development of acquired dysphagia. The incidence of dysphagia and ICU acquired weakness (ICUAW) in subjects with \\>48h of intubation and the relative risk factors associated with baseline characteristics and clinical variables will be described. METHODOLOGY: Design: Single-center cohort study (Ramón y Cajal University Hospital). Participants: subjects \\>18 years old, admitted to an intensive care unit (ICU), with \\>48 hours of orotracheal intubation who meet eligibility criteria. Outcomes: the study of socio-demographic and clinical variables related to ICU admission will be included. The physical function variables will be analyzed through the Medical Research Council (MRC) and Functional Status Score (FSS), as well as swallowing function variables through the Volume-Viscosity Swallow (VVS-T) and Functional Oral Intake Scale scales. (FOIS) and Gugging Swallowing Screen (GUSS). Measurements will be made of the thickness and echogenicity of the submental and tongue muscles, as well as hyolaryngeal kinematics",[57,58,59],"Dysphagia, Oropharyngeal","Deglutition Disorders","Mechanical Ventilation Complication",[61,62,63,64,65],"Dysphagia","Ultrasonography","Deglutition disorders","Diagnostic Imaging","Mechanical ventilation","NOT_YET_RECRUITING","2024-06-27",{"date":69,"type":70},"2024-07-01","ACTUAL",{"date":72,"type":52},"2024-06",{"date":74,"type":52},"2025-06",{"name":5,"class":6}]