A Predictive Model for Oropharyngeal Dysphagia in Non-hospitalized Older Patients

NCT05862142 | Unknown

• 1 other identifier: IIBSP-DOF-2022-121
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Oropharyngeal dysphagia (OD) is a highly prevalent and growing condition in the older population. It affects approximately one in three community-dwelling elderly, almost half of the geriatric patients, and even more than half of elderly nursing home residents. The main complications of OD are respiratory infections such as aspiration pneumonia, malnutrition, and dehydration. It supposes substantial costs for the healthcare system, increases the risk for (re)admissions and length of stay, and has an important impact on the quality of life of people who suffer from it. The aim of this study is to develop a predictive model to identify non-hospitalized older patients at risk for oropharyngeal dysphagia, quantify that risk, and facilitate decision-making according to personal, clinical, and socio-emotional characteristics.

Conditions

Deglutition Disorders; Otorhinolaryngologic Diseases; Oropharyngeal Dysphagia

Keywords

Older people; Predictive models

Outcome Measures

Primary Outcomes (4)

• Dysphagia Outcome and Severity Scale (DOSS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)

  It is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia based on objective assessment and make recommendations for diet level, independence level, and type of nutrition Range: 1 Nothing by mouth (NPO) - 7 Full oral intake, normal.

  Up to 8 years

• Penetration Aspiration Scale (PAS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)

  It is a is a rank ordered scale that classifies the depth of penetrated or aspirated material and the patient's response to airway invasion. Range: 1 No airway penetration - 8 Airway aspiration, no cough.

  Up to 8 years

• Bolus Residue Scale (BRS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)

  It is a simple, easy-to-carry-out, and accessible analysis method to rate and locate pharyngeal retention. Range: 1 No residue - 6 Residue in valleculae and posterior pharyngeal wall and piriform sinus.

  Up to 8 years

• Functional Oral Intake Scale (FOIS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)

  It is a reliable and valid tool to assess functional oral intake of food and liquids in patients with oropharyngeal dysphagia (OD). Range: 1 Nothing by mouth (NPO) - 7 Full oral intake without restrictions.

  Up to 8 years

Secondary Outcomes (1)

• Predictive value of pharyngeal width at rest for aspiration (JOSCYL width). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)

  Up to 8 years

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Older patients (≥ 65 years) referred to the Physical Medicine and Rehabilitation Service of Hospital de la Santa Creu i Sant Pau for a swallowing study between 2015 and 2023.

You may qualify if:

• Older people between 65 and 99 years.
• Swallowing assessed with Videofluoroscopy
• Non-hospitalized patients (swallowing assessed on an outpatient basis)

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

MeSH Terms

Conditions

Deglutition Disorders; Otorhinolaryngologic Diseases

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases

Central Study Contacts

Víctor Najas Sales, SLP

CONTACT

+34696554925; vnajas@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: June 6, 2023
• Primary Completion: August 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-05