NCT06630013 A New Ultrasound Score for Swallowing Disorders Diagnosis in Difficult-to-wean Tracheostomised Patients

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 114 participants in total. It began in 2024-07-09 with a primary completion date of 2026-12-01.

Brief Summary

Swallowing Disorders (SD) is commonly observed in intensive care unit (ICU) patients. Disruption to the upper airway by way of a tracheostomy may lead to physiological and/or biomechanical changes to the swallow, thereby increasing dysphagia risk. SD is independently associated with adverse outcomes including respiratory complications, nutritional compromise, and even death. Experts recommend a systematic bedside screening. Most algorithms include the water swallow test followed by expert comprehensive swallowing assessments of screening positive patients. However, the clinical examination lacks precision. Complementary examinations, such as videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing (FEES), are irradiating or invasive, consume numerous resources and are difficult to access. No current consensus exists on how to best approach to evaluate ICU patients at risk. In this context, US imaging has garnered increased interest for assessing swallowing disorders. Recognised for its non-invasive nature and its ability to overcome conventional constraints, this approach, enabling both qualitative and quantitative analysis of multiple structures, would enhance the precision in targeting structures for rehabilitation. The researchers intend to create an ultrasound diagnostic model for difficult-to-wean trahceostomised patients. Additionally, they aim to evaluate the reliability and accuracy of this model. During an nineteen-months period, we will enrolled one hundred and nineteen difficult-to-wean tracheostomised patients at Forcilles's Hospital, Universitary Hospital of Dijon, Béthune Hospital and Bourgon Jallieu Hospital. All patients will have a FEES evaluation. The ultrasonographer will be blinded to the patient's status and prior clinical or imaging assessments. Ultrasound assessment will focus on evaluating the movements or morphology of structures such as the tongue, laryngeal movement, or suprahyoid muscles. A global ultrasound diagnostic model will be developed after selecting variables in logistic multivariable regression. Its sensitivity and specificity and prediction value will be estimated. The constructed model will be transformed in an easy-to-use scoring system. The study anticipates establishing an association between ultrasound markers and swallowing disorders, aiming to enhance early detection for tailored management strategies, providing a non-invasive alternative to videofluoroscopy or FEES.

Eligibility Criteria

Inclusion Criteria: * Patients admitted to ICU and tracheostomised for difficult-to-wean reasons ; * Patients with a medical indication for nasofibroscopy ; * Medical prescription for physiotherapy assessment ; * Ultrasound operator available ; * Patient at least 18 years old at the time of inclusion; * Oral, free, informed and express patient consent Exclusion Criteria: * Patient with total laryngectomy; * History of swallowing disorders prior to critical care admission; * History of central nervous system disorders (stroke, Parkinson's disease, etc.) * Patient admitted to intensive care following central neurological injury; * Patient with spinal cord injury above C5 ; * Patient's refusal to participate in the study ; * Known pregnancy ; * Cognitive impairment incompatible with understanding instructions; * Patient under guardianship; * Patient with limited care.

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