RecruitingNCT07734298DISFEXUpdated Jul 29, 2026

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

An interventional study of Bedside Cervical Ultrasonography and Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in Swallowing Disorders and Aspiration, sponsored by Hospital H+ Queretaro. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Hospital H+ Queretaro · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

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.

Conditions studied

Swallowing Disorders
Aspiration

Browse trials for

Deglutition Disorders 708

Keywords

post-extubation dysphagia
Critical care ultrasonography
Swallowing disorders

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts 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

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).

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 40 participants (estimated)

Study arms

Experimental
Diagnostic Evaluation Group
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

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

What researchers measure

Primary outcomes

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.
Time frame: At 48 hours post-extubation.

Secondary outcomes

Diagnostic Sensitivity and Specificity.
Calculation of the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of cervical ultrasonography for detecting dysphagia, using FEES as the clinical reference standard.
Time frame: At 48 hours post-extubation.
Ultrasonographic Parameter Cut-off Points.
Determination of optimal threshold values for ultrasonographic measurements, including hyoid bone displacement (mm) and laryngeal elevation, that correlate with the presence of dysphagia or aspiration.
Time frame: At 48 hours post-extubation.
Incidence of Respiratory Complications.
Frequency of adverse events, specifically bronchoaspiration, the need for re-intubation, or the development of post-extubation pneumonia.
Time frame: From ICU admission through ICU discharge, up to 30 days

Study locations

1 of 1 sites recruiting

Hospital H+
Querétaro City, Querétaro 7600, Mexico
Recruiting

Registry details

Key details

Study ID: NCT07734298
Lead sponsor: Hospital H+ Queretaro
Responsible party: Jose J Zaragoza, MD MSc (Principal Investigator, Hospital H+ Queretaro) — Principal investigator
First posted: Jul 29, 2026
Start date: Jul 27, 2026 (estimated)
Primary completion: Aug 1, 2026 (estimated)
Completion: Aug 31, 2026 (estimated)
Last update: Jul 29, 2026

Study contacts

Amy Sevilla Valle

Contact

sevillavalleamy@gmail.com

+505-8557-2609

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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