SURE Trial: Swallowing Ultrasound Reliability Evaluation Trial

NCT ID: NCT07098767

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2027-10-31

Brief Summary

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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

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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.

Conditions

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Dysphagia Swallowing Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

ultrasound evaluation

Intervention Type 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)

Intervention Type 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.

Interventions

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ultrasound evaluation

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.

Intervention Type DIAGNOSTIC_TEST

Fiberoptic endoscopic evaluation of swallowing (FEES)

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shu-mei Yang, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shu-mei Yang, MD

Role: CONTACT

0972653675

Facility Contacts

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Shu-mei Yang, MD

Role: primary

0972653675

References

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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.

Reference Type BACKGROUND
PMID: 36188819 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7858370 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33741822 (View on PubMed)

Other Identifiers

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202406013RINA

Identifier Type: -

Identifier Source: org_study_id

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