Bedside Screening Method for Patients With Potential Swallowing Impairment

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01158313

Acronym

CABS

Enrollment

120

Registered

2010-07-08

Start date

2010-07-31

Completion date

2011-08-31

Last updated

2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deglutition Disorders, Dysphagia

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).

Interventions

DIETARY_SUPPLEMENTThickened 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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026