Clinical Trial

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

Study acronym: DISFEX
Recruiting
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Record status
This record was last updated July 29, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07734298
Lead Sponsor Hospital H+ Queretaro
Conditions Swallowing Disorders, Aspiration
Enrollment 40 participants
Start Date 2026-07-27
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-29