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Clinical Trials in Mexico / NCT07734298
Recruiting Not applicable

Ultrasound vs. Nasofibroscopy for Evaluating Dysphagia After Extubation in the ICU

NCT07734298 · tracked via the Priya Life Science Mexico tracker
Sponsor
Hospital H+ Queretaro
Phase
Not applicable
Started
2026-07-27
Last updated
2026-07-29

Condition(s) studied

Swallowing DisordersAspiration

Investigational drug(s) / intervention(s)

Bedside Cervical UltrasonographyFiberoptic Endoscopic Evaluation of Swallowing (FEES)

Bedside Cervical Ultrasonography: Measurement of anatomical swallowing-related structures (hyoid bone and larynx) using a convex or linear transducer at the patient's bedside.

Fiberoptic Endoscopic Evaluation of Swallowing (FEES): Endoscopic visualization of the larynx and pharynx during the administration of various bolus consistencies to assess swallowing safety.

Study summary

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:

* What is the degree of diagnostic concordance (Kappa index) between cervical ultrasonography and nasofibroscopy (FEES) for detecting dysphagia in the Intensive Care Unit (ICU)?
* What are the sensitivity, specificity, and predictive values of ultrasonography as a non-invasive screening tool compared to the gold standard (FEES)?
* 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Critically ill patients admitted to the Intensive Care Unit (ICU). * Patients aged 18 years or older. * Patients who have required orotracheal intubation and mechanical ventilation for a period exceeding 48 hours. * Patients successfully liberated from mechanical ventilation (post-extubation phase). * Obtainment of signed Informed Consent from the patient or their legal representative. Exclusion Criteria: * Patients with a known prior history of oropharyngeal dysphagia, esophageal disorders, or structural abnormalities of the upper airway. * 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). * Patients with a history of head and neck surgery or radiotherapy. * Patients with a Glasgow Coma Scale (GCS) score \< 13 at the time of evaluation. * Patients with hemodynamic instability or severe respiratory distress that precludes the diagnostic procedures. * Anatomical limitations that prevent the correct placement of the ultrasound transducer or the introduction of the nasofibroscope (e.g., severe facial trauma, nasal obstruction). * Medical contraindication for Fiberoptic Endoscopic Evaluation of Swallowing (FEES).

Primary outcome measure(s)

  • Diagnostic Concordance (Kappa Index). — At 48 hours post-extubation.
    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.

Trial sites (1)

FacilityCityRegionStatus
Hospital H+ Querétaro City Querétaro Recruiting

More Hospital H+ Queretaro trials in Mexico

Standardization of IMT Dosage (UTIT) in Mechanical Ventilation. Enrolling by invitation
Fecal Lactate and Resuscitation Outcomes in Critical Illness Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07734298 on ClinicalTrials.gov ↗ ← All trials in Mexico