Construction and Evaluation of a New Ultrasound Score for the Diagnosis of Swallowing Disorders in Difficult-to-wean Tracheostomised Patients

What this Trial Is About

Swallowing disorders are common in intensive care unit (ICU) patients, especially those with tracheostomies that can cause changes affecting swallowing. These disorders are linked to serious problems like respiratory issues, poor nutrition, and even death. Current clinical exams lack precision, while existing tests like videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing (FEES) are invasive, resource-heavy, and hard to access. Researchers are exploring ultrasound imaging as a non-invasive and precise method to assess swallowing disorders in difficult-to-wean tracheostomised ICU patients. This observational study will enroll 119 difficult-to-wean tracheostomised patients over nineteen months at multiple hospitals. Each patient will undergo FEES and ultrasound evaluations within a two-hour window. Ultrasound will assess movements and structures including the tongue, larynx, and suprahyoid muscles. The ultrasonographer will be blinded to other assessments. The goal is to develop a diagnostic ultrasound model using selected variables, which will be transformed into an easy-to-use scoring system to predict swallowing disorders. Participants will be assessed through clinical data collection and swallowing tests. Ultrasound exams will measure features like tongue thickness and muscle contractions, while FEES will evaluate swallowing function and residue severity. Reliability tests will be done with multiple examiners. Researchers will analyze data statistically to create and validate the ultrasound score’s accuracy and reliability. The study aims to improve early detection and management of swallowing disorders non-invasively, over the course of the study period ending in April 2026.

A New Ultrasound Score for Swallowing Disorders Diagnosis in Difficult-to-wean Tracheostomised Patients