Ultrasound vs. Nasofibroscopy for Evaluating Dysphagia After Extubation in the ICU (NCT07734298) | Clinical Trial Compass
RecruitingNot Applicable
Ultrasound vs. Nasofibroscopy for Evaluating Dysphagia After Extubation in the ICU
Mexico40 participantsStarted 2026-07-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.