Deglutition DisordersVASESNCT06742034
Translation and Validation of the Visual Analysis of Swallowing Efficiency and Safety Into European Portuguese
An observational study of Deglutition Disorders and Deglutition, run by Centro Hospitalar de Entre o Douro e Vouga at 1 site in Portugal.
Trial summary
The goal of this observational study is to translate and validate to European Portuguese "Visual Analysis of Swallowing Efficiency and Safety - VASES". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deglutition Disorders, Deglutition
- How many people
- 34 participants
- Where
- 1 sitePortugal
- Study dates
- 31 Jan 2023to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who underwent FEES at the ULSEDV and met the study's inclusion and exclusion criteria.
Who may be able to join
- 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.
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar de Entre Douro e Vouga
Santa Maria da Feira, 4520-211
About this study
The goal of this observational study is to translate and validate to European Portuguese "Visual Analysis of Swallowing Efficiency and Safety - VASES".
- Conditions
- Deglutition Disorders, Deglutition
- Keywords
- Dysphagia, Instrumental Assessment, Swallowing Disorders, Fiberoptic Endoscopic Evaluation of Swallow
- Medical subject headings
- Deglutition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliable and validated European Portuguese version of the VASES
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.
Measured: patients with neurological and/or mechanical oropharyngeal dysphagia evaluated FEES up to 3 months after the first symptomatology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start31 Jan 2023
- Primary completion30 Mar 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar de Entre o Douro e Vouga
- Sponsor type
- University, hospital or other
- Collaborators
- Aveiro University
- Responsible party
- Principal investigator, Daniela Ferreira, Centro Hospitalar de Entre o Douro e Vouga
- Investigators
- Daniela Filipa Brás Ferreira, Master, Principal investigator, Unidade Local de Saúde de Entre Douro e Vouga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742034
- Sponsor's protocol ID
- 242023
- Acronym
- VASES
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the Visual Analysis of Swallowing Efficiency and Safety Into European Portuguese
- ClinicalTrials.gov ID
- NCT06742034
- Acronym / sponsor ID
- VASES / 242023
- Conditions
- Deglutition Disorders, Deglutition
- Keywords
- Dysphagia, Instrumental Assessment, Swallowing Disorders, Fiberoptic Endoscopic Evaluation of Swallow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centro Hospitalar de Entre o Douro e VougaUniversity, hospital or other
- Collaborators
- Aveiro University
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to translate and validate to European Portuguese "Visual Analysis of Swallowing Efficiency and Safety - VASES".
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent FEES at the ULSEDV and met the study's inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Filipa Brás Ferreira, Master principal investigator
Unidade Local de Saúde de Entre Douro e Vouga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition Disorders and Deglutition, run by Centro Hospitalar de Entre o Douro e Vouga at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.