Ultrasound vs. Nasofibroscopy for Evaluating Dysphagia After Extubation in the ICU
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bedside Cervical Ultrasonography, Fiberoptic Endoscopic Evaluation of Swallowing (FEES).
- Who it may be relevant to
- Registry conditions: Swallowing Disorders, Aspiration. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison Between Ultrasonographic and Nasofibroscopic Evaluation in Extubated Patients With Dysphagia in the Intensive Care Unit.
Overview
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.
Interventions
- 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. - Diagnostic test Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Endoscopic visualization of the larynx and pharynx during the administration of various bolus consistencies to assess swallowing safety.
Primary outcome measures
- Diagnostic Concordance (Kappa Index). [Time frame: At 48 hours post-extubation.]
Secondary outcome measures (3)
- Diagnostic Sensitivity and Specificity. [Time frame: At 48 hours post-extubation.]
- Ultrasonographic Parameter Cut-off Points. [Time frame: At 48 hours post-extubation.]
- Incidence of Respiratory Complications. [Time frame: From ICU admission through ICU discharge, up to 30 days]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Mexico · 1 center
- Hospital H+ — Querétaro City
Identifiers
NCT: NCT07734298 · CEI2026-04/02/V1 · Hospital H +, Queretaro