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SURE Trial: Swallowing Ultrasound Reliability Evaluation Trial

Investigating the Reliability of Using Ultrasonography to Assess Swallowing Function in Patients With Dysphagia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07098767
Enrollment
80
Registered
2025-08-01
Start date
2024-11-01
Completion date
2027-10-31
Last updated
2025-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Swallowing Disorder

Keywords

dysphagia, ultrasonography, swallowing assessment

Brief summary

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_TESTultrasound 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.

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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Reliability of Ultrasonography in Swallowing Function AssessmentImmediate post-assessment.Comparison with FEES findings

Secondary

MeasureTime frameDescription
Diagnostic AccuracyImmediate post-assessment.Sensitivity, specificity, positive predictive value, and negative predictive value of US in detecting dysphagia.

Countries

Taiwan

Contacts

Primary ContactShu-mei Yang, MD
b99401109@gmail.com0972653675

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026