NCT06558435

Brief Summary

The goal of this observational study is to translate and validate the fiberoptic endoscopic evaluation of swallowing scale "The Boston Residue and Clearance Scale - BRACS" to European Portuguese

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

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

March 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

Same day

First QC Date

August 14, 2024

Last Update Submit

August 19, 2024

Conditions

Keywords

Swallowing DisordersDysphagiaFiberoptic Endoscopic Evaluation of Swallowing

Outcome Measures

Primary Outcomes (1)

  • Reliable and validated European Portuguese version of the BRACS

    Demonstrating the reliability and validity of the Boston Residue and Clearance Scale in diagnosing dysphagia during fiberoptic endoscopic assessment of swallowing examination. BRACS it's an 11-point ordinal residue classification scale that assesses 3 aspects: the amount and location of pharyngolaryngeal residues, the presence of spontaneous swallowing to clear it and the effectiveness of patient's swallowing.

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

Interventions

FEESOTHER

Single group

Also known as: Fiberoptic Endoscopic Evaluation of Swallowing

Eligibility Criteria

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

Patients with neurological or mechanical dysphagia who have undergone a FEES examination and whose test meets the inclusion criteria described above.

You may qualify if:

  • FEES recording that allowed good visualisation of the pharynx and larynx.
  • FEES recording of patients after head and neck surgery who had anatomical alterations of the structures, but which did not interfere with good visualisation of the residues.
  • FEES recording of patients with a tracheostomy or under tube feeding.

You may not qualify if:

  • FEES recording of patients 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

Interventions

Fees and Charges

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and Organizations

Study Design

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

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 16, 2024

Study Start

March 1, 2023

Primary Completion

March 1, 2023

Study Completion

May 1, 2023

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations