SURE Trial: Swallowing Ultrasound Reliability Evaluation Trial

NCT07098767 | Recruiting

• 1 other identifier: 202406013RINA
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Swallowing Disorder

Keywords

dysphagia; ultrasonography; swallowing assessment

Outcome Measures

Primary Outcomes (1)

• Reliability of Ultrasonography in Swallowing Function Assessment

  Comparison with FEES findings

  Immediate post-assessment.

Secondary Outcomes (1)

• Diagnostic Accuracy

  Immediate post-assessment.

Study Arms (1)

Dysphagia patients

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.

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

Interventions

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.

Dysphagia patients

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.

Dysphagia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients aged 18 years and older who have been referred for dysphagia evaluation. Participants will have varying degrees of swallowing difficulty, stemming from conditions such as stroke, head and neck cancer, or neurodegenerative diseases. Eligible individuals will have a Functional Oral Intake Scale (FOIS) score between 2 and 6. The population will be recruited from both outpatient and inpatient settings within the rehabilitation department of National Taiwan University Hospital. Patients must be conscious and able to follow instructions, ensuring accurate participation in both ultrasonography and fiberoptic endoscopic evaluation of swallowing (FEES). Those with unstable vital signs, acute infections, mechanical ventilation, or cognitive impairments preventing effective participation will be excluded from the study.

You may qualify if:

• Adults aged 18 or older.
• Dysphagia patients referred for swallowing assessments.
• FOIS score between 2-6.

You may not qualify if:

• Unconscious patients or those unable to follow instructions.
• Unstable vital signs.
• Acute infections or mechanical ventilation.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (3)

• Hsiao MY, Wu CH, Wang TG. Emerging Role of Ultrasound in Dysphagia Assessment and Intervention: A Narrative Review. Front Rehabil Sci. 2021 Aug 11;2:708102. doi: 10.3389/fresc.2021.708102. eCollection 2021.

  PMID: 36188819 BACKGROUND

• Dunn CJ, Fitton A, Sorkin EM. Etidronic acid. A review of its pharmacological properties and therapeutic efficacy in resorptive bone disease. Drugs Aging. 1994 Dec;5(6):446-74. doi: 10.2165/00002512-199405060-00006.

  PMID: 7858370 BACKGROUND

• Allen JE, Clunie GM, Winiker K. Ultrasound: an emerging modality for the dysphagia assessment toolkit? Curr Opin Otolaryngol Head Neck Surg. 2021 Jun 1;29(3):213-218. doi: 10.1097/MOO.0000000000000708.

  PMID: 33741822 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Shu-mei Yang, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-mei Yang, MD

CONTACT

0972653675; b99401109@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: August 1, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: August 1, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)