SURE Trial: Swallowing Ultrasound Reliability Evaluation Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ultrasound evaluation, Fiberoptic endoscopic evaluation of swallowing (FEES).
- Who it may be relevant to
- Registry conditions: Dysphagia, Swallowing Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigating the Reliability of Using Ultrasonography to Assess Swallowing Function in Patients With Dysphagia
Overview
This study aims to explore the reliability of using ultrasonography (US) for the assessment of swallowing function in patients with dysphagia. The study will recruit 80 patients and compare the findings with those obtained from fiberoptic endoscopic evaluation of swallowing (FEES), which serves as the gold standard.
Detailed description
This study will evaluate the reliability of using ultrasonography as a non-invasive tool for assessing swallowing function in patients with dysphagia. Participants will undergo US and FEES assessments to examine vocal cord function, swallowing reflex, pharyngeal contraction, aspiration/penetration, and stasis. The reliability, diagnostic accuracy, and inter-/intra-rater reliability will be analyzed to validate US as an effective alternative in clinical dysphagia assessment.
Interventions
- Diagnostic test ultrasound evaluation
Use high-frequency ultrasonography to assess the swallowing function in patients with dysphagia. The ultrasound examination focuses on visualization of the pharyngeal region to measure vocal cord movement, swallowing reflex, pharyngeal contraction, and the presence and location of pharyngeal residue. - Diagnostic test Fiberoptic endoscopic evaluation of swallowing (FEES)
FEES involves the use of a flexible endoscope inserted through the nasal passage to observe the pharyngeal phase of swallowing directly. This procedure allows for the real-time assessment of key aspects of swallowing, including vocal cord function, swallowing reflex, pharyngeal contraction, and the detection of aspiration or penetration.
Primary outcome measures
- Reliability of Ultrasonography in Swallowing Function Assessment [Time frame: Immediate post-assessment.]
Secondary outcome measures (1)
- Diagnostic Accuracy [Time frame: Immediate post-assessment.]
Eligibility criteria
Inclusion criteria
- Adults aged 18 or older.
- Dysphagia patients referred for swallowing assessments.
- FOIS score between 2-6.
Exclusion criteria
- Unconscious patients or those unable to follow instructions.
- Unstable vital signs.
- Acute infections or mechanical ventilation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Publications
- Hsiao MY, Wu CH, Wang TG. Emerging Role of Ultrasound in Dysphagia Assessment and Intervention: A Narrative Review. Front Rehabil Sci. 2021 Aug 11;2:708102. doi: 10.3389/fresc.2021.708102. eCollection 2021. PMID 36188819
- Dunn CJ, Fitton A, Sorkin EM. Etidronic acid. A review of its pharmacological properties and therapeutic efficacy in resorptive bone disease. Drugs Aging. 1994 Dec;5(6):446-74. doi: 10.2165/00002512-199405060-00006. PMID 7858370
- Allen JE, Clunie GM, Winiker K. Ultrasound: an emerging modality for the dysphagia assessment toolkit? Curr Opin Otolaryngol Head Neck Surg. 2021 Jun 1;29(3):213-218. doi: 10.1097/MOO.0000000000000708. PMID 33741822
Identifiers
NCT: NCT07098767 · 202406013RINA