[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649377":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":47,"collaborators":21,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":21,"enrollmentInfo":61,"targetDuration":21,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":35,"whyStopped":21,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Hospital H+ Queretaro","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Diagnostic Evaluation Group","EXPERIMENTAL","This is a single-arm study where all participants who have been extubated after more than 48 hours of mechanical ventilation will undergo a sequential diagnostic assessment.\n\nEach participant will receive:\n\n* Cervical Ultrasonography: A non-invasive bedside evaluation to measure hyoid bone displacement and laryngeal elevation.\n* Fiberoptic Endoscopic Evaluation of Swallowing (FEES): The gold standard endoscopic procedure to visualize the pharyngeal and laryngeal phases of swallowing and detect penetration or aspiration.",[13,14],"Diagnostic Test: Bedside Cervical Ultrasonography","Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing (FEES)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DIAGNOSTIC_TEST","Bedside Cervical Ultrasonography","Measurement of anatomical swallowing-related structures (hyoid bone and larynx) using a convex or linear transducer at the patient's bedside.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Fiberoptic Endoscopic Evaluation of Swallowing (FEES)","Endoscopic visualization of the larynx and pharynx during the administration of various bolus consistencies to assess swallowing safety.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Amy Sevilla Valle","CONTACT","+505-8557-2609","sevillavalleamy@gmail.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":21},"Hospital H+","RECRUITING","Querétaro City","Querétaro","7600","Mexico","MX",{"type":42,"coordinates":43},"Point",[44,45],-100.38806,20.58806,{"lat":45,"lon":44},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Jose J Zaragoza, MD MSc","Principal Investigator","100649377","ultrasound-vs-nasofibroscopy-for-evaluating-dysphagia-after-extubation-in-the-icu-100649377",false,"NCT07734298","Ultrasound vs. Nasofibroscopy for Evaluating Dysphagia After Extubation in the ICU","Comparison Between Ultrasonographic and Nasofibroscopic Evaluation in Extubated Patients With Dysphagia in the Intensive Care Unit.","DISFEX","Inclusion Criteria:\n\n* Critically ill patients admitted to the Intensive Care Unit (ICU).\n* Patients aged 18 years or older.\n* Patients who have required orotracheal intubation and mechanical ventilation for a period exceeding 48 hours.\n* Patients successfully liberated from mechanical ventilation (post-extubation phase).\n* Obtainment of signed Informed Consent from the patient or their legal representative.\n\nExclusion Criteria:\n\n* Patients with a known prior history of oropharyngeal dysphagia, esophageal disorders, or structural abnormalities of the upper airway.\n* Patients with pre-existing neurological diseases that compromise the swallowing reflex (e.g., advanced Parkinson's disease, previous stroke with residual dysphagia, Amyotrophic Lateral Sclerosis).\n* Patients with a history of head and neck surgery or radiotherapy.\n* Patients with a Glasgow Coma Scale (GCS) score \\\u003C 13 at the time of evaluation.\n* Patients with hemodynamic instability or severe respiratory distress that precludes the diagnostic procedures.\n* Anatomical limitations that prevent the correct placement of the ultrasound transducer or the introduction of the nasofibroscope (e.g., severe facial trauma, nasal obstruction).\n* Medical contraindication for Fiberoptic Endoscopic Evaluation of Swallowing (FEES).","ALL","18 Years",{"count":62,"type":63},40,"ESTIMATED","INTERVENTIONAL",[66],"NA","The goal of this observational study is to evaluate the diagnostic performance and concordance of bedside cervical ultrasonography compared to Fiberoptic Endoscopic Evaluation of Swallowing (FEES) for the early detection of post-extubation dysphagia in critically ill adult patients.\n\nThe main questions it aims to answer are:\n\n* What is the degree of diagnostic concordance (Kappa index) between cervical ultrasonography and nasofibroscopy (FEES) for detecting dysphagia in the Intensive Care Unit (ICU)?\n* What are the sensitivity, specificity, and predictive values of ultrasonography as a non-invasive screening tool compared to the gold standard (FEES)?\n* Are there specific cut-off points for ultrasonographic parameters (such as hyoid bone displacement and laryngeal elevation) that accurately identify patients at risk of aspiration? Methodology and Comparison: Researchers will evaluate a cohort of patients who have undergone mechanical ventilation for more than 48 hours. The study compares the findings of cervical ultrasonography (an accessible and non-invasive bedside method) with FEES (the clinical gold standard) to determine the feasibility of ultrasound as an initial screening tool in the ICU setting. Participant Tasks: Participants will undergo the following procedures within 24 to 48 hours post-extubation: A bedside cervical ultrasonography to measure swallowing-related anatomical movements, such as hyoid displacement and laryngeal elevation. A nasofibroscopy (FEES) performed by trained personnel to directly visualize the pharyngeal and laryngeal structures during swallowing. A clinical evaluation of cranial nerve function and monitoring for respiratory complications like bronchoaspiration or pneumonia.",[69,70],"Swallowing Disorders","Aspiration",[72,73,74],"post-extubation dysphagia","Critical care ultrasonography","Swallowing disorders","2026-07-27",{"date":77,"type":78},"2026-07-29","ACTUAL",{"date":75,"type":63},{"date":81,"type":63},"2026-08-31",{"name":5,"class":6},1]