Clinical trial NCT01158313: Bedside Screening Method for Patients With Potential Swallowing Impairment
Official title: Development and Validation of Clinician-administered Bedside Screening Method for Patients With Potential Swallowing Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deglutition Disorders
Dysphagia
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2010-07-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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).


Eligibility 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

Primary outcomes:
measure: Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of oropharyngeal dysphagia.
timeFrame: 24 hour period
measure: Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of safety in swallowing.
timeFrame: 24 hour period
measure: Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of efficacy in swallowing.
timeFrame: 24 hour period
Secondary outcomes:
measure: Sensitivities and specificities of the V-VST relative to VFS for individual signs of impaired safety and efficacy
timeFrame: 24 hour timeframe
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Hospital Mataro
Study officials:
References:
citation: 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.