Prevalence of Respiratory Aspiration in Patients With COPD

Study Overview
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Brief Summary
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The aim of the study is to estimate the prevalence of respiratory aspiration in patients with COPD, in a tertiary hospital of Buenos Aires.

Detailed Description
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Primary objective To estimate the prevalence of respiratory aspiration in patients with COPD, in a tertiary hospital of Buenos Aires. Secondary objective To assess the association between the presence of aspiration and the usual degree of dyspnea in patients with COPD. To assess the association between the presence of aspiration and the amount of regular annual exacerbations in patients with COPD. To evaluate the association between the presence of aspiration and degree of severity according to GOLD criteria in patients with COPD. Compare the estimated aspiration in COPD patients with known prevalence of pulmonary aspiration in the general population in the same age patient prevalence Patients will be recruited consecutively in the outpatient clinic of Pulmonology and Medical Clinic, where a first encounter with the patient will be agreed. Additionally, the investigators will cite patients identified as COPD in the Electronic Medical Records. During the first meeting the informed consent process to enter the protocol will take place, then the same baseline characteristics of the patient is taken into an online form. Finally given a shift within 15 days after the first meeting for the FEEST, and if the patient did not have a spirometry over the past year to update a new turn. Both studies will be conducted without any cost. In patients with impaired swallowing or aspiration presence is detected, we will inform the doctor to assess the need for additional studies. In turn, the patients will be referred to speech therapy services for rehabilitation of swallowing.

Official Title
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Prevalence of Respiratory Aspiration in Patients With COPD: Cross-sectional Study

Conditions
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COPD

Intervention / Treatment
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* Procedure: FEESST


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - Patients over 64 years diagnosed with chronic obstructive pulmonary disease guide GOLD criteria (FEV1 / FVC ratio post bronchodilator <0.70) Exclusion Criteria Refusal to participate or to process oral informed consent Contraindication for the FEESST (history of vasovagal episodes, bilateral nasal obstruction, impaired homeostasis or frequent bleeding, dyskinesia, maxillofacial trauma or recent neck). Impaired understanding or cognition that hinder the consent or performing diagnostic tests required. Diagnosis of neurodegenerative disease associated with swallowing disorders known: Parkinson, stroke with neurologic sequelae.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspiration in COPD patients<br>All COPD patient will be evaluated systematically by FEESST (Flexible Endoscopic Evaluation of Swallowing with Sensory Testing) with direct evaluation of aspiration by direct observation. | Procedure: FEESST<br>* Flexible Endoscopic Evaluation of Swallowing with Sensory Testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of any consistence Airway Aspiration | Direct observation of any consistence food (liquid/semisolid/solid) penetration or aspiration by direct inspection with Flexible Endoscopic Evaluation of Swallowing with Sensory Testing. There is no follow-up period as this is a prevalence study. All measurements will be done at time 0. The only experimental feature (according to ClinicalTrials.gov definitions) is that we use FEEST to detect evidence of airway aspiration and this is not a routine examination in COPD patients. | Baseline (Time 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspiration Risk | Direct observation of indirect signs of high risk for aspiration with Flexible Endoscopic Evaluation of Swallowing with Sensory Testing. There is no follow-up period as this is a prevalence study. All measurements will be done at time 0. The only experimental feature (according to ClinicalTrials.gov definitions) is that we use FEEST to detect evidence of airway aspiration and this is not a routine examination in COPD patients. | Baseline (Time 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Respiratory Aspiration, COPD acute exacerbation