Bedside Screening Method for Patients With Potential Swallowing Impairment

Completed

• Conditions: Dysphagia; Deglutition Disorders
• Interventions: Dietary Supplement: Thickened supplement

• Registration Number: NCT01158313
• Lead Sponsor: Société des Produits Nestlé (SPN)

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-22
• Study Start: 2010-07
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Primary Completion: 2011-07
• Study Completion: 2011-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thickener	Thickened supplement	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of efficacy in swallowing.	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.
Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of oropharyngeal dysphagia.	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.
Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of safety in swallowing.	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.

Secondary Outcome Measures

Name	Time	Method
Sensitivities and specificities of the V-VST relative to VFS for individual signs of impaired safety and efficacy	24 hour timeframe

Trial Locations

Locations (1)

Hospital Mataro; 🇪🇸 Mataró, Spain