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Bedside Screening Method for Patients With Potential Swallowing Impairment (CABS)

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ClinicalTrials.gov Identifier: NCT01158313
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
Previous studies have shown that most patients with functional oropharyngeal dysphagia could be quickly, safely and accurately recognized by using a clinical bedside method developed by the investigative team as the volume-viscosity swallow test (V-VST) that systematically evaluates the main clinical signs and symptoms of safety and efficacy of swallowing and monitors pulse oximetry to improve the detection of patients with silent aspirations.The aim of this study is to validate this test for persons suspected of having swallowing impairment, using a new thickener, with respect to the Videofluoroscopy (VFS) method (treated as the gold standard).

Condition or disease Intervention/treatment
Deglutition Disorders Dysphagia Dietary Supplement: Thickened supplement

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Development and Validation of Clinician-administered Bedside Screening Method for Patients With Potential Swallowing Impairment
Study Start Date : July 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Thickener

Patients with history of swallowing difficulties associated with aging and/or neurological diseases including patients with:

  • neurodegenerative diseases.
  • non-progressive neurological diseases including stroke.
  • older patients including nursing home patients.
Dietary Supplement: Thickened supplement
New thickener to be mixed to liquid to obtain different viscosities such as nectar viscosity, honey viscosity, conservative spoon-thick viscosity (CST) and extreme spoon-thick viscosity (EST



Primary Outcome Measures :
  1. Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of oropharyngeal dysphagia. [ Time Frame: 24 hour period ]
    Diagnostic accuracy in terms of sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of oropharyngeal dysphagia.

  2. Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of safety in swallowing. [ Time Frame: 24 hour period ]
    Diagnostic accuracy in terms of sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of safety in swallowing.

  3. Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of efficacy in swallowing. [ Time Frame: 24 hour period ]
    Diagnostic accuracy in terms of sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of efficacy in swallowing.


Secondary Outcome Measures :
  1. Sensitivities and specificities of the V-VST relative to VFS for individual signs of impaired safety and efficacy [ Time Frame: 24 hour timeframe ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
120 Patients suspected of having symptoms of swallowing impairment will be enrolled in the study as well as 14 healthy volunteers
Criteria

Inclusion Criteria:

  • History of swallowing difficulties associated with aging and/or neurological diseases including patients with: -neurodegenerative diseases. -non-progressive neurological diseases including stroke. -older patients including nursing home patients.
  • Age > 18 y
  • Ability to give informed consent

Exclusion Criteria:

  • Patients suffering idiosyncratic phenomena or who are allergic to any medication, especially iodinated contrast media
  • Patients suffering major respiratory disease or undergoing any type of surgery in the three months prior to the study
  • Patients with a background of alcohol dependence or other drug dependence
  • Patient who cannot be expected to comply with treatment
  • Patient currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158313


Locations
Spain
Hospital Mataro
Mataró, Spain, 08304
Sponsors and Collaborators
Nestlé

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01158313     History of Changes
Other Study ID Numbers: HCN-DYS
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases