Ultrasound checks for swallowing in adults with dysphagia

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

This project will test whether ultrasound can do the same swallowing checks as FEES for adults with dysphagia.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (other)
• Locations: 1 site (Taipei)
• Trial ID: NCT07098767 on ClinicalTrials.gov

What this trial studies

This observational study will enroll 80 adults with dysphagia and perform both ultrasound (US) and fiberoptic endoscopic evaluation of swallowing (FEES) on each participant. Examinations will look at vocal cord movement, swallowing reflex timing, pharyngeal contraction, aspiration/penetration, and stasis. Results from US will be compared with FEES as the reference standard, and analyses will include diagnostic accuracy and inter- and intra-rater reliability. The goal is to validate whether US can serve as a reliable, non-invasive alternative or adjunct to FEES in clinical swallowing assessment.

Who should consider this trial

Good fit: Adults aged 18 or older with dysphagia referred for swallowing assessment and a FOIS score between 2 and 6 are the intended participants.

Not a fit: Unconscious patients, those unable to follow instructions, patients with unstable vital signs, acute infections, or those on mechanical ventilation would not be eligible and thus would not benefit from participation.

Why it matters

Potential benefit: If successful, ultrasound could provide a non-invasive, bedside alternative to FEES that makes swallowing evaluation easier, quicker, and safer for many patients.

How similar studies have performed: Small pilot studies have shown that ultrasound can visualize swallowing structures and show promise, but direct comparisons with FEES are limited and broader validation is still needed.

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.

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Shu-mei Yang, MD — National Taiwan University Hospital
• Study coordinator: Shu-mei Yang, MD

Conditions: Dysphagia, Swallowing Disorder, dysphagia, ultrasonography, swallowing assessment