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NCT Number: NCT07098767

SURE Trial: Swallowing Ultrasound Reliability Evaluation Trial

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Swallowing Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Shu-mei Yang, MD

CONTACT

[email protected]

0972653675

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound evaluation

Diagnostic Test

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.

Fiberoptic Endoscopic Evaluation of Swallowing (FEES)

Diagnostic Test

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.

Primary outcomes

  1. Reliability of Ultrasonography in Swallowing Function Assessment

    Time frame: Immediate post-assessment.

    Comparison with FEES findings

Secondary outcomes

  1. Diagnostic Accuracy

    Time frame: Immediate post-assessment.

    Sensitivity, specificity, positive predictive value, and negative predictive value of US in detecting dysphagia.

Study contacts

Contact information is provided by the study sponsor or research team.

Shu-mei Yang, MD

CONTACT

[email protected]

0972653675

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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