NCT07098767

SURE Trial: Swallowing Ultrasound Reliability Evaluation Trial

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Dysphagia
• Swallowing Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2025-08-01
• Last updated: 2025-08-01

Locations

1 site across 1 country: Taiwan