An interventional study of Bedside Cervical Ultrasonography and Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in Swallowing Disorders and Aspiration, sponsored by Hospital H+ Queretaro. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Hospital H+ Queretaro · Not applicable, Interventional, and Diagnostic
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.
The main questions it aims to answer are:
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Hospital H+ Queretaro is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
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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.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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. Each participant will receive: * Cervical Ultrasonography: A non-invasive bedside evaluation to measure hyoid bone displacement and laryngeal elevation. * 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.
Diagnostic Test: Bedside Cervical Ultrasonography · Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Measurement of anatomical swallowing-related structures (hyoid bone and larynx) using a convex or linear transducer at the patient's bedside.
Endoscopic visualization of the larynx and pharynx during the administration of various bolus consistencies to assess swallowing safety.
Diagnostic Concordance (Kappa Index).
The degree of diagnostic agreement between bedside cervical ultrasonography and Fiberoptic Endoscopic Evaluation of Swallowing (FEES) for the detection of post-extubation dysphagia. This will be evaluated using Cohen's Kappa coefficient to determine if ultrasonography is a reliable alternative to the gold standard.
Time frame: At 48 hours post-extubation.
Diagnostic Sensitivity and Specificity.
Calculation of the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of cervical ultrasonography for detecting dysphagia, using FEES as the clinical reference standard.
Time frame: At 48 hours post-extubation.
Ultrasonographic Parameter Cut-off Points.
Determination of optimal threshold values for ultrasonographic measurements, including hyoid bone displacement (mm) and laryngeal elevation, that correlate with the presence of dysphagia or aspiration.
Time frame: At 48 hours post-extubation.
Incidence of Respiratory Complications.
Frequency of adverse events, specifically bronchoaspiration, the need for re-intubation, or the development of post-extubation pneumonia.
Time frame: From ICU admission through ICU discharge, up to 30 days
Start is estimated for Jul 2026; primary completion for Aug 2026, 0 months later.
Of 288 non-industry interventional studies with no phase under Deglutition Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 0 months is below that.
Counting every sponsor, half of 297 studies reached it within 21 months; a quarter within 10 and three quarters within 38.
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