NCT06742034

Brief Summary

The goal of this observational study is to translate and validate to European Portuguese "Visual Analysis of Swallowing Efficiency and Safety - VASES".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

December 16, 2024

Last Update Submit

December 16, 2024

Conditions

Keywords

DysphagiaInstrumental AssessmentSwallowing DisordersFiberoptic Endoscopic Evaluation of Swallow

Outcome Measures

Primary Outcomes (1)

  • 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.

    patients with neurological and/or mechanical oropharyngeal dysphagia evaluated FEES up to 3 months after the first symptomatology

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar de Entre Douro e Vouga

Santa Maria da Feira, 4520-211, Portugal

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Daniela Filipa Brás Ferreira, Master

    Unidade Local de Saúde de Entre Douro e Vouga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Speech and Language Pathologist

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 19, 2024

Study Start

January 31, 2023

Primary Completion

March 30, 2023

Study Completion

March 30, 2024

Last Updated

December 19, 2024

Record last verified: 2024-12

Locations