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Videofluoroscopic Swallowing Study (VFSS) (PORSCHE)

Primary Purpose

Stroke, Parkinson Disease, Multiple Sclerosis

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Dysphagia Detection System
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center
  • University of Colorado Denver
  • Medstar Rehabilitation Hospital
  • Shirley Ryan AbilityLab
  • Marionjoy Rehabilitation Hospital
  • Kentucky Clinic
  • Boston Medical Center
  • Henry Ford Health System
  • New York Presbyterian/Weill Cornell Medical Center
  • New York Presbyterian Hospital/Columbia University Medical Center
  • The Burke Medical Research Institute
  • The Cleveland Clinic Foundation
  • Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single-arm Dysphagia Detection System

Arm Description

An operationally seamless single-arm, prospective, multicenter, single-blinded for central outcomes assessors trial to test DDS in assessing swallowing safety and efficiency in patients at risk of oropharyngeal dysphagia.

Outcomes

Primary Outcome 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 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.

Secondary Outcome Measures

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.
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 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 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 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.

Full Information

First Posted
October 30, 2017
Last Updated
April 29, 2021
Sponsor
Société des Produits Nestlé (SPN)
Collaborators
Cytel Inc., Regulatory and Clinical Research Institute Inc, Nestec Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03387267
Brief Title
Videofluoroscopic Swallowing Study (VFSS)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to futility
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
July 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
Collaborators
Cytel Inc., Regulatory and Clinical Research Institute Inc, Nestec Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Parkinson Disease, Multiple Sclerosis, Oropharyngeal Dysphagia, Alzheimer Disease, Dementia

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The clinical trial will initially start as a 3-look group sequential design (GSD). Alpha-spending will be calculated using Lan-DeMets spending function (with O'Brien-Fleming parameter). At the first interim analysis (IA-1) the threshold on the ROC curve may be re-computed using the ROC curve generated using the IA-1 data, in which case, the validation trial would start afresh following IA-1 using a 2-look GSD. Data included in the IA-1 would no longer be used for the validation phase.
Masking
None (Open Label)
Masking Description
An operationally seamless single-arm, prospective, multicenter, single-blinded for central outcomes assessors trial to test DDS in assessing swallowing safety and efficiency in patients at risk of oropharyngeal dysphagia.
Allocation
N/A
Enrollment
452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single-arm Dysphagia Detection System
Arm Type
Other
Arm Description
An operationally seamless single-arm, prospective, multicenter, single-blinded for central outcomes assessors trial to test DDS in assessing swallowing safety and efficiency in patients at risk of oropharyngeal dysphagia.
Intervention Type
Device
Intervention Name(s)
Dysphagia Detection System
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
The study procedure of simultaneous VFSS and DDS measurement using thin barium (THIN-Ba) was completed in one day for each subject.
Secondary Outcome Measure Information:
Title
AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MILD-Ba
Description
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.
Time Frame
The study procedure of simultaneous VFSS and DDS measurement using mild barium (MILD-Ba) was completed in one day for each subject.
Title
AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MOD-Ba
Description
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.
Time Frame
The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.
Title
The Sensitivity & Specificity for Swallow Efficiency Using THIN-Ba
Description
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.
Time Frame
The study procedure of simultaneous VFSS and DDS measurement using THIN-Ba was completed in one day for each subject.
Title
The Sensitivity & Specificity for Swallow Efficiency Using MILD-Ba
Description
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.
Time Frame
The study procedure of simultaneous VFSS and DDS measurement using MILD-Ba was completed in one day for each subject.
Title
The Sensitivity & Specificity for Swallow Efficiency Using MOD-Ba
Description
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.
Time Frame
The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia Muhlemann, MD
Organizational Affiliation
Nestle Health Science
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Richard Harvey, MD
Organizational Affiliation
Shirley Ryan AbilityLab (Rehabilitation Institute of Chicago)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Medstar Rehabilitation Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Marionjoy Rehabilitation Hospital
City
Wheaton
State/Province
Illinois
ZIP/Postal Code
60187
Country
United States
Facility Name
Kentucky Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
New York Presbyterian/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Presbyterian Hospital/Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
The Burke Medical Research Institute
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25850008
Citation
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.
Results Reference
background
PubMed Identifier
20713754
Citation
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.
Results Reference
background
PubMed Identifier
16109909
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. doi: 10.1161/01.STR.0000177529.86868.8d. Epub 2005 Aug 18.
Results Reference
background
PubMed Identifier
21213454
Citation
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.
Results Reference
background
PubMed Identifier
23412377
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. No abstract available.
Results Reference
background
PubMed Identifier
25581840
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.
Results Reference
background
PubMed Identifier
24026520
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.
Results Reference
background
PubMed Identifier
1595983
Citation
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.
Results Reference
background
PubMed Identifier
17024550
Citation
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.
Results Reference
background
PubMed Identifier
16623312
Citation
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.
Results Reference
background

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Videofluoroscopic Swallowing Study (VFSS)

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