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

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

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).

Study Overview

• Status: Completed
• Conditions: Deglutition Disorders; Dysphagia
• Intervention / Treatment: Dietary supplement: Thickened supplement

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Spain
  • Mataró, Spain, 08304
    • Hospital Mataró

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nestlé

Publications and helpful links

General Publications

• Rofes L, Arreola V, Mukherjee R, Swanson J, Clave P. The effects of a xanthan gum-based thickener on the swallowing function of patients with dysphagia. Aliment Pharmacol Ther. 2014 May;39(10):1169-79. doi: 10.1111/apt.12696. Epub 2014 Mar 13.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: June 22, 2010
• First Submitted That Met QC Criteria: July 7, 2010
• First Posted (ESTIMATE): July 8, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 30, 2013
• Last Update Submitted That Met QC Criteria: October 29, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: HCN-DYS