Swallowing Difficulty Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Mexico
Hospital H+
RECRUITING
Querétaro City
Contact Information
Primary
Amy Sevilla Valle
sevillavalleamy@gmail.com
+505-8557-2609
Time Frame
Start Date: 2026-07-27
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Hospital H+ Queretaro

This content was sourced from clinicaltrials.gov