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

Recruitingn/aAges 18 Years - anyAllHopital Forcilles
NCT06630013 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

4 sites
Ch de Béthune
Beuvry, France
CHU Dijon Bourgogne
Dijon, France
Groupement Hospitalier Nord Dauphiné, CH Bourgoin-Jallieu
Lyon, France
Hôpital Forcilles
Férolles-Attilly, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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