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

Study acronym: SHUBACA
StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 10 months later Feb 1, 2026 → Dec 1, 2026
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Record History

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  1. Notable Primary completion pushed from Feb 1, 2026 to Dec 1, 2026 Show 5 more changesShow less
    • Study completion pushed from Apr 1, 2026 to Feb 6, 2028
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site contacts updated at 4 of 4 sites
    • Study description expanded, about 5 words
  2. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06630013
Lead Sponsor Hopital Forcilles
Conditions
(from sponsor)
Deglutition Disorders
Related terms Deglutition Disorders
Enrollment 114 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov