Translation and Validation of the Visual Analysis of Swallowing Efficiency and Safety Into European Portuguese (VASES)

December 16, 2024 updated by: Daniela Ferreira, Centro Hospitalar de Entre o Douro e Vouga
The goal of this observational study is to translate and validate to European Portuguese "Visual Analysis of Swallowing Efficiency and Safety - VASES".

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Santa Maria Da Feira, Portugal, 4520-211
        • Centro Hospitalar de Entre Douro e Vouga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent FEES at the ULSEDV and met the study's inclusion and exclusion criteria.

Description

Inclusion Criteria:

  • Patient's FEES recording that allowed good visualization of the pharynx and larynx;
  • FEES recording from patients after head and neck surgery who had structural alterations but still did not interfere with a clear visualization of the residues.
  • Patient's tracheostomized or under enteral nutrition.

Exclusion Criteria:

  • Under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliable and validated European Portuguese version of the VASES
Time Frame: patients with neurological and/or mechanical oropharyngeal dysphagia evaluated FEES up to 3 months after the first symptomatology
Visual Analysis of Swallowing Efficiency and Safety (VASES) is a standardized approach for rating pharyngeal residue, penetration, and aspiration during FEES. It establishes clearly defined anatomic and temporal boundaries within which to rate functional swallowing outcomes.
patients with neurological and/or mechanical oropharyngeal dysphagia evaluated FEES up to 3 months after the first symptomatology

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar de Entre o Douro e Vouga

Collaborators

Aveiro University

Investigators

  • Principal Investigator: Daniela Filipa Brás Ferreira, Master, Unidade Local de Saúde de Entre Douro e Vouga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

March 30, 2024

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 242023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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