Masseter and Thigh Muscle Ultrasound to Predict Dysphagia and Sarcopenia in Critically Ill Adults

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 single-center observational study will examine the relationship between masseter and rectus femoris muscle thickness measured by ultrasound and the presence of post-extubation dysphagia and sarcopenia in critically ill adults. Dysphagia will be assessed with the MECVVm test, while ultrasound data will be analyzed for diagnostic accuracy and association with clinical outcomes. The goal is to determine whether bedside muscle ultrasound can provide objective information to identify patients at risk of dysphagia and sarcopenia after extubation or in tracheostomized patients. Eligible participants are adults who required invasive ventilation for more than 48 hours and are awake, extubated within 6-36 hours or tracheostomized and tolerating breathing without ventilation for at least 6 hours daily. Exclusion criteria include pre-existing dysphagia or inability to complete assessment within 36 hours post-extubation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years.
* Critically ill patients requiring invasive mechanical ventilation for \>48 hours.
* Extubated patients: extubation 6-36 hours before study assessment.
* Tracheostomized patients: surgical or percutaneous tracheostomy considered clinically suitable to initiate oral feeding, tolerating spontaneous breathing without mechanical ventilation for at least 6 hours/day, and negative cuff-leak test.
* Awake and cooperative, with effective cough and ability to manage oral secretions.
* Written informed consent obtained.

Exclusion Criteria:

* Documented pre-existing oropharyngeal dysphagia.
* Inability to undergo study assessment within 36 hours after extubation.
* In tracheostomized patients, positive cuff-leak test before study assessment.

Where it's running

• Hospital General Universitario Gregorio Marañón
  Madrid, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Sara Casanova Prieto, Md
• Email: sara.casanova@salud.madrid.org
• Phone: +34665286063

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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.