SURE Trial: Swallowing Ultrasound Reliability Evaluation Trial
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 or older.
Dysphagia patients referred for swallowing assessments.
FOIS score between 2-6.
Disqualifiers
Unconscious patients or those unable to follow instructions.
Unstable vital signs.
Acute infections or mechanical ventilation.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ultrasound evaluation
Diagnostic testUse 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 testFEES 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Dysphagia patients2 interventions
Trial outcomes
Primary outcomes
1
Reliability of Ultrasonography in Swallowing Function Assessment
Comparison with FEES findings
Time frame
Immediate post-assessment.Secondary outcomes
1
Diagnostic Accuracy
Sensitivity, specificity, positive predictive value, and negative predictive value of US in detecting dysphagia.
Time frame
Immediate post-assessment.Sponsors and contacts
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Source ClinicalTrials.gov