SURE Trial: Swallowing Ultrasound Reliability Evaluation Trial

National Taiwan University

Status: Enrolling

Conditions: Dysphagia; Swallowing Disorder

Treatments: Diagnostic Test: Fiberoptic endoscopic evaluation of swallowing (FEES); Diagnostic Test: ultrasound evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT07098767

202406013RINA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

80 participants in 1 patient group

Dysphagia patients

Description:

This cohort consists of patients with dysphagia undergoing swallowing function assessments. Participants will undergo two types of assessments: ultrasonography and fiberoptic endoscopic evaluation of swallowing (FEES), to evaluate key parameters of swallowing function.

Treatment:

Diagnostic Test: Fiberoptic endoscopic evaluation of swallowing (FEES)

Diagnostic Test: ultrasound evaluation