Videofluoroscopic Swallowing Study (VFSS)
A Prospective Multi-center Study Comparing the Performance of the Dysphagia Detection System (DDS) in Detecting Impaired Swallowing Safety and Efficiency as Compared to the Clinical Reference Method - Videofluoroscopic Swallowing Study
What it found
The trial was stopped early because the treatment was not working.
Reason given: Study terminated due to futility
What was tested
Treatment tested
- Dysphagia Detection System
Results by group
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
The study procedure of simultaneous VFSS and DDS measurement using thin barium (THIN-Ba) was completed in one day for each subject.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Single-arm Dysphagia Detection System | 0.64 Probability | 242 |
AUC under ROC curve 0.64
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Dysphagia Detection System (DDS) | 438 | 5 (1.1%) | 1 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
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
The study procedure of simultaneous VFSS and DDS measurement using thin barium (THIN-Ba) was completed in one day for each subject.
How the body handles the medicineSafety
Other measures (5)
AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MILD-Ba
The study procedure of simultaneous VFSS and DDS measurement using mild barium (MILD-Ba) was completed in one day for each subject.
How the body handles the medicineSafetyAUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MOD-Ba
The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.
How the body handles the medicineSafetyThe Sensitivity & Specificity for Swallow Efficiency Using THIN-Ba
The study procedure of simultaneous VFSS and DDS measurement using THIN-Ba was completed in one day for each subject.
The Sensitivity & Specificity for Swallow Efficiency Using MILD-Ba
The study procedure of simultaneous VFSS and DDS measurement using MILD-Ba was completed in one day for each subject.
The Sensitivity & Specificity for Swallow Efficiency Using MOD-Ba
The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
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 the neck (e.g., knife wound) resulting in musculoskeletal or nerve injury in the neck. * Received radiation or chemotherapy to the oropharynx or neck for cancer. * Allergy to oral radiographic contrast media (specifically barium) * Distorted oropharyngeal anatomy (e.g. pharyngeal pouch) * Cognitive impairment that prevents them from being able to comply with study instructions and procedures * Known to be pregnant at the time of enrollment * Currently has significant facial hair at the location of sensor adherence and are unwilling/unable to be shaved * Any patients the local investigator finds that participation would not be in patients' best interest
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
Clave P, Shaker R. Dysphagia: current reality and scope of the problem. Nat Rev Gastroenterol Hepatol. 2015 May;12(5):259-70. doi: 10.1038/nrgastro.2015.49. Epub 2015 Apr 7.Background
Altman KW, Yu GP, Schaefer SD. Consequence of dysphagia in the hospitalized patient: impact on prognosis and hospital resources. Arch Otolaryngol Head Neck Surg. 2010 Aug;136(8):784-9. doi: 10.1001/archoto.2010.129.Background
Hinchey JA, Shephard T, Furie K, Smith D, Wang D, Tonn S; Stroke Practice Improvement Network Investigators. Formal dysphagia screening protocols prevent pneumonia. Stroke. 2005 Sep;36(9):1972-6. doi: 10.1161/01.STR.0000177529.86868.8d. Epub 2005 Aug 18.Background
Management of Stroke Rehabilitation Working Group. VA/DOD Clinical practice guideline for the management of stroke rehabilitation. J Rehabil Res Dev. 2010;47(9):1-43. No abstract available.Background
Donovan NJ, Daniels SK, Edmiaston J, Weinhardt J, Summers D, Mitchell PH; American Heart Association Council on Cardiovascular Nursing and Stroke Council. Dysphagia screening: state of the art: invitational conference proceeding from the State-of-the-Art Nursing Symposium, International Stroke Conference 2012. Stroke. 2013 Apr;44(4):e24-31. doi: 10.1161/STR.0b013e3182877f57. Epub 2013 Feb 14. No aBackground
O'Horo JC, Rogus-Pulia N, Garcia-Arguello L, Robbins J, Safdar N. Bedside diagnosis of dysphagia: a systematic review. J Hosp Med. 2015 Apr;10(4):256-65. doi: 10.1002/jhm.2313. Epub 2015 Jan 12.Background
Kertscher B, Speyer R, Palmieri M, Plant C. Bedside screening to detect oropharyngeal dysphagia in patients with neurological disorders: an updated systematic review. Dysphagia. 2014 Apr;29(2):204-12. doi: 10.1007/s00455-013-9490-9. Epub 2013 Sep 13.Background
Swets JA. The science of choosing the right decision threshold in high-stakes diagnostics. Am Psychol. 1992 Apr;47(4):522-32. doi: 10.1037//0003-066x.47.4.522.Background
Zammit-Maempel I, Chapple CL, Leslie P. Radiation dose in videofluoroscopic swallow studies. Dysphagia. 2007 Jan;22(1):13-5. doi: 10.1007/s00455-006-9031-x. Epub 2006 Oct 6.Background
Moro L, Cazzani C. Dynamic swallowing study and radiation dose to patients. Radiol Med. 2006 Feb;111(1):123-9. doi: 10.1007/s11547-006-0013-8. English, Italian.
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History
Started
Oct 2017
Main results due
Jul 2018
Finished
Jul 2018
Results posted
May 2021