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

Официальное название

Comparison Between Ultrasonographic and Nasofibroscopic Evaluation in Extubated Patients With Dysphagia in the Intensive Care Unit.

Обзор

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.

Вмешательства

• Диагностический тест Bedside Cervical Ultrasonography
  Measurement of anatomical swallowing-related structures (hyoid bone and larynx) using a convex or linear transducer at the patient's bedside.
• Диагностический тест Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
  Endoscopic visualization of the larynx and pharynx during the administration of various bolus consistencies to assess swallowing safety.

Первичные конечные точки

• Diagnostic Concordance (Kappa Index). [Срок оценки: At 48 hours post-extubation.]

Вторичные конечные точки (3)

• Diagnostic Sensitivity and Specificity. [Срок оценки: At 48 hours post-extubation.]
• Ultrasonographic Parameter Cut-off Points. [Срок оценки: At 48 hours post-extubation.]
• Incidence of Respiratory Complications. [Срок оценки: From ICU admission through ICU discharge, up to 30 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Мексика · 1 центр

• Hospital H+ — Querétaro City

Идентификаторы

NCT: NCT07734298 · CEI2026-04/02/V1 · Hospital H +, Queretaro

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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