Ultrasound vs. Nasofibroscopy for Evaluating Dysphagia After Extubation in the ICU
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital H+ Queretaro
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Bedside Cervical Ultrasonography
Diagnostic testMeasurement of anatomical swallowing-related structures (hyoid bone and larynx) using a convex or linear transducer at the patient's bedside.
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Diagnostic testEndoscopic visualization of the larynx and pharynx during the administration of various bolus consistencies to assess swallowing safety.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Diagnostic Evaluation GroupExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
At 48 hours post-extubation.Secondary outcomes
1
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.2
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.3
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 daysSponsors and contacts
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Source ClinicalTrials.gov