Videofluoroscopic Swallowing Study (VFSS) (NCT03387267) | Clinical Trial Compass
TerminatedNot Applicable
Videofluoroscopic Swallowing Study (VFSS)
Stopped: Study terminated due to futility
United States452 participantsStarted 2017-10-24
Plain-language summary
The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and the subject will be followed within 2 business days after the study procedure to monitor for adverse events.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult subjects (over 18 years of age)
* Hospitalized subjects or outpatients identified as at risk of oropharyngeal dysphagia (using local practice)
* Patients belong to one of the following groups:
* Stroke patients
* Traumatic brain injury
* Parkinson Disease (PD) stage III or higher by Hoehn and Yahr scale
* Multiple Sclerosis (MS) above age 60
* Alzheimer Disease (AD) or other Dementia
* Other medically complex hospitalized subjects not covered by the exclusion criteria and identified as at risk of dysphagia
* Subject is able to comply with VFSS protocol to diagnose dysphagia
* Subject is able to give voluntary, written informed consent to participate in the clinical investigation and from whom consent has been obtained / or a consultee has consented on he subjects behalf in line with nationally agreed guidelines concerning adults unable to consent for themselves.
Exclusion Criteria:
* Presence of nasogastric / nasojejunal feeding tube at the time of VFSS test
* Currently has a tracheostomy, or has had a tracheostomy in the past year
* Had posterior cervical spine surgery and/or carotid endarterectomy in the last 6 months
* Had significant surgery to the mouth and/or neck, for example resection for oral or pharyngeal cancer, radical neck dissection, anterior cervical spine surgery, orofacial reconstruction, pharyngoplasty, or thyroidectomy. Routine tonsillectomy and/or adenoidectomy are not excluded
* Experienced non-surgical trauma to …
What they're measuring
1
Area Under the Receiver Operating Characteristic (ROC) Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for THIN-Ba
Timeframe: The study procedure of simultaneous VFSS and DDS measurement using thin barium (THIN-Ba) was completed in one day for each subject.