Bedside Screening Method for Patients With Potential Swallowing Impairment

Dysphagia Clinical Trial

— CABS  

Official title:

Development and Validation of Clinician-administered Bedside Screening Method for Patients With Potential Swallowing Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158313
• Other study ID #: HCN-DYS
• Status: Completed
• Phase: N/A
• First received: June 22, 2010
• Last updated: October 29, 2013
• Start date: July 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Mataro	Mataró

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of oropharyngeal dysphagia.	Diagnostic accuracy in terms of sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of oropharyngeal dysphagia.	24 hour period	No
Primary	Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of safety in swallowing.	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.	24 hour period	No
Primary	Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of efficacy in swallowing.	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.	24 hour period	No
Secondary	Sensitivities and specificities of the V-VST relative to VFS for individual signs of impaired safety and efficacy		24 hour timeframe	No