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

NCT07734298 | Recruiting

• 2 other identifiers: CEI2026-04/02/V1Hospital H +, Queretaro
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Swallowing Disorders; Aspiration

Keywords

post-extubation dysphagia; Critical care ultrasonography; Swallowing disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  At 48 hours post-extubation.

Secondary Outcomes (3)

• Diagnostic Sensitivity and Specificity.

  At 48 hours post-extubation.

• Ultrasonographic Parameter Cut-off Points.

  At 48 hours post-extubation.

• Incidence of Respiratory Complications.

  From ICU admission through ICU discharge, up to 30 days

Study Arms (1)

Diagnostic Evaluation Group

EXPERIMENTAL

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)

Interventions

Bedside Cervical Ultrasonography DIAGNOSTIC_TEST

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

Diagnostic Evaluation Group

Fiberoptic Endoscopic Evaluation of Swallowing (FEES) DIAGNOSTIC_TEST

Endoscopic visualization of the larynx and pharynx during the administration of various bolus consistencies to assess swallowing safety.

Diagnostic Evaluation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital H+ Queretaro: lead

Study Sites (1)

Hospital H+

Querétaro City, Querétaro, 7600, Mexico

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Amy Sevilla Valle

CONTACT

+505-8557-2609; sevillavalleamy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 29, 2026
• Study Start: July 27, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

ME (1)