SURE Trial: Swallowing Ultrasound Reliability Evaluation Trial

Recruiting

• Conditions: Dysphagia; Swallowing Disorder

• Registration Number: NCT07098767
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-11-01
• Study First Submitted: 2024-11-03
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-08-01
• Last Update Posted: 2025-08-01
• Primary Completion: 2026-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reliability of Ultrasonography in Swallowing Function Assessment	Immediate post-assessment.	Comparison with FEES findings

Secondary Outcome Measures

Name	Time	Method
Diagnostic Accuracy	Immediate post-assessment.	Sensitivity, specificity, positive predictive value, and negative predictive value of US in detecting dysphagia.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan