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Completed

NCT Number: NCT06558435

Validation of BRACS to European Portuguese

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Hospitalar de Entre Douro e Vouga

Santa Maria da Feira, 4520-211, Portugal

About this study

The Boston Residue and Clearance Scale (BRACS) is a multidimensional scale developed and validated to assess the severity of residues observed during fiberoptic endoscopic evaluation of swallowing (FEES).

It differs from other FEES residue scales, since it considers all aspects related to pharyngolaryngeal residues, specifically, the location, amount and the patient's clearance ability.

The purpose of this study was to translate and cross-culturally adapt the English version of the BRACS into European Portuguese and to investigate the reliability and validity of the translated version of the scale.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • FEES recording of patients under 18 years of age.

Treatment and study plan

FEES

Other

Single group

Other names: Fiberoptic Endoscopic Evaluation of Swallowing

Primary outcomes

  1. Reliable and validated European Portuguese version of the BRACS

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

    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.

Sponsors and collaborators

Lead sponsor

Centro Hospitalar de Entre o Douro e Vouga

Other

Registry information

Official study title

Translation and Validation of "The Boston Residue and Clearance Scale" to European Portuguese

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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