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

This study is currently recruiting participants.
Verified June 2012 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01158313
First received: June 22, 2010
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Deglutition Disorders
Dysphagia
 Dietary Supplement: Thickened supplement

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Development and Validation of Clinician-administered Bedside Screening Method for Patients With Potential Swallowing Impairment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of oropharyngeal dysphagia. [ Time Frame: 24 hour period ] [ Designated as safety issue: No ]
    Diagnostic accuracy in terms of sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of oropharyngeal dysphagia.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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:
  • Sensitivities and specificities of the V-VST relative to VFS for individual signs of impaired safety and efficacy [ Time Frame: 24 hour timeframe ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158313

Contacts
Contact: Pere Clave, MD, PHD +34 93 741 77 00. pclave@teleline.es

Locations
Spain
Hospital Mataro Recruiting
Mataró, Spain, 08304
Principal Investigator: Pere Clave, Md, PHD            
Sponsors and Collaborators
Nestlé
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01158313     History of Changes
Other Study ID Numbers: HCN-DYS
Study First Received: June 22, 2010
Last Updated: June 21, 2012
Health Authority: Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on May 19, 2013