Videofluoroscopic Swallowing Study (VFSS)

Stroke Clinical Trial

— PORSCHE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03387267
• Other study ID #: 16.21.CLI
• Status: Terminated
• Phase: N/A
• Start date: October 24, 2017
• Est. completion date: July 23, 2018

Study information

• Verified date: January 2019
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

DDS signals and VFSS will be recorded simultaneously (for the same bolus) using barium contrast agent stimuli prepared in three consistencies: thin, mildly-thick and moderately-thick. Subjects will undergo VFSS with simultaneous DDS using up to 5 boluses of thin barium stimulus ("THIN-Ba"), and up to 4 boluses of barium thickened to mildly ("MILD-Ba") thick and up to 4 boluses of moderately ("MODERATE-Ba") thick barium consistencies using Resource Thicken Up Clear Nestlé Health Science (TUC). 4, 3 and 3 boluses for THIN-Ba, MILD-Ba and MOD-Ba will be analyzed using the classifier algorithms for sensitivity/specificity results. According to the exploratory trial, VFSS data for safety or efficiency can be missing for up to 14% boluses due to quality of VFSS recording. To compensate for potential losses of boluses due to missing gold standard (VFSS) data, 5, 4 and 4 boluses will be collected for the three consistencies respectively . The DDS signals will be sent to a dedicated application software installed at the CRO, which interprets the acceleration data and displays the examination result. The VFSS recording will be sent to CRO and provided for blinded assessment by the independent central VFSS laboratory.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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 452
• Est. completion date: July 23, 2018
• Est. primary completion date: July 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Deglutition Disorders
• Dementia
• Multiple Sclerosis
• Oropharyngeal Dysphagia
• Parkinson Disease
• Stroke

Intervention

Device:
• Dysphagia Detection System
The Nestle Health Sciences (NHSc) Dysphagia Detection System (DDS) is a portable, non-invasive device designed for use at the bedside. The investigational DDS has 3 basic components: Sensor Unit (suspended on a necklace), Sensor Fixation and a personal computer (PC) for collecting data. The Sensor Unit consists of a dual-axis accelerometer in a plastic housing that is attached to the front of a patient's neck just below the thyroid cartilage by the single-use, disposable fixation unit. The Sensor Unit is connected via a cable to an A/D converter which then connects via cable to the PC. The PC collects the examination data, which is then sent to dedicated application software (installed at the CRO), which interprets the acceleration data and displays the examination result.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
United States	University of Colorado Denver	Aurora	Colorado
United States	Boston Medical Center	Boston	Massachusetts
United States	Shirley Ryan AbilityLab	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	Kentucky Clinic	Lexington	Kentucky
United States	New York Presbyterian Hospital/Columbia University Medical Center	New York	New York
United States	New York Presbyterian/Weill Cornell Medical Center	New York	New York
United States	Medstar Rehabilitation Hospital	Washington	District of Columbia
United States	Marionjoy Rehabilitation Hospital	Wheaton	Illinois
United States	The Burke Medical Research Institute	White Plains	New York

Sponsors (4)

Lead Sponsor	Collaborator
Nestlé	Cytel Inc., Nestec Ltd., Regulatory and Clinical Research Institute Inc

Countries where clinical trial is conducted

United States,  Finland, 

References & Publications (10)

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. — View Citation

Clavé 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. Review. — View Citation

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. — View Citation

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. Epub 2005 Aug 18. — View Citation

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. Review. — View Citation

Moro L, Cazzani C. Dynamic swallowing study and radiation dose to patients. Radiol Med. 2006 Feb;111(1):123-9. English, Italian. — View Citation

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. Review. — View Citation

Swets JA. The science of choosing the right decision threshold in high-stakes diagnostics. Am Psychol. 1992 Apr;47(4):522-32. — View Citation

VA/DoD Clinical Practice Guideline for the October, 2010. Management of Stroke Rehabilitation

Zammit-Maempel I, Chapple CL, Leslie P. Radiation dose in videofluoroscopic swallow studies. Dysphagia. 2007 Jan;22(1):13-5. Epub 2006 Oct 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 primary efficacy of the DDS was measured as the sensitivity & specificity obtained from comparing the DDS predicted swallow safety outcome (binary) with the clinical reference standard VFSS swallow safety outcome (binary) for thin barium (THIN-Ba) stimuli, using 5 boluses per subject protocol. ROC (AUC) was used for comparing the 2 algorithms.; The ROC curve incorporates both sensitivity (true positive rate) and specificity (true negative rate) providing a single assessment incorporating both measures. The higher the total area under the curve, the greater the predictive power of the outcome.; Primary analysis for futility was based on 242 subjects (Interim Analysis). The study was terminated based on futility as the AUC for primary endpoint (0.64) was less than the guiding futility bound of 0.75.	The study procedure of simultaneous VFSS and DDS measurement using thin barium (THIN-Ba) was completed in one day for each subject.
Secondary	AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MILD-Ba	The sensitivity & specificity obtained from comparing the DDS predicted swallow safety outcome (binary) with the clinical reference standard VFSS swallow safety outcome (binary) for MILD barium (MILD-Ba) stimuli, using 4 boluses per subject protocol. ROC (AUC) was used for comparing the 2 algorithms. The higher the total AUC, the greater the predictive power of the outcome.	The study procedure of simultaneous VFSS and DDS measurement using mild barium (MILD-Ba) was completed in one day for each subject.
Secondary	AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MOD-Ba	The sensitivity & specificity obtained from comparing the DDS predicted swallow safety outcome (binary) with the clinical reference standard VFSS swallow safety outcome (binary) for MODERATE barium (MOD-Ba) stimuli, using 3 boluses per subject protocol. ROC (AUC) was used for comparing the 2 algorithms. The higher the total AUC, the greater the predictive power of the outcome.	The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.
Secondary	The Sensitivity & Specificity for Swallow Efficiency Using THIN-Ba	The sensitivity & specificity obtained from comparing the DDS predicted swallow efficiency outcome (binary) with the clinical reference standard VFSS swallow efficiency outcome (binary) for Thin barium (THIN-Ba) stimuli.	The study procedure of simultaneous VFSS and DDS measurement using THIN-Ba was completed in one day for each subject.
Secondary	The Sensitivity & Specificity for Swallow Efficiency Using MILD-Ba	The sensitivity & specificity obtained from comparing the DDS predicted swallow efficiency outcome (binary) with the clinical reference standard VFSS swallow efficiency outcome (binary) for MILD-Ba.	The study procedure of simultaneous VFSS and DDS measurement using MILD-Ba was completed in one day for each subject.
Secondary	The Sensitivity & Specificity for Swallow Efficiency Using MOD-Ba	The sensitivity & specificity obtained from comparing the DDS predicted swallow efficiency outcome (binary) with the clinical reference standard VFSS swallow efficiency outcome (binary) for MOD-Ba stimuli.	The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.