Ultrasound vs Nasofibroscopy to see if post-extubation swallowing problems show up in ICU

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational analysis compares cervical ultrasonography with FEES for early detection of post-extubation dysphagia in critically ill adults. It will measure diagnostic concordance using the kappa statistic and evaluate sensitivity, specificity, and predictive values of ultrasound against FEES as the reference standard. The study also aims to identify ultrasound cut-off points for indicators like hyoid bone movement and laryngeal elevation that flag aspiration risk. Eligible participants are adults in the ICU who required prolonged mechanical ventilation, have been extubated, and can provide consent. Exclusion criteria include preexisting swallowing disorders, severe neurological disease affecting swallowing, head/neck surgery or radiotherapy history, low GCS, or instability that precludes safe participation.

Why it matters

Who can join: the full rules

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).

Where it's running

• Hospital H+
  Querétaro City, Querétaro, Mexico Recruiting

Study contacts

• Study coordinator: Amy Sevilla Valle
• Email: sevillavalleamy@gmail.com
• Phone: +505-8557-2609

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.