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Prevalence of Respiratory Aspiration in Patients With COPD

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02722629
Enrollment
330
Registered
2016-03-30
Start date
2016-06-30
Completion date
2017-07-31
Last updated
2016-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD, Respiratory Aspiration, COPD acute exacerbation

Brief summary

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

Primary objective To estimate the prevalence of respiratory aspiration in patients with COPD, in a tertiary hospital of Buenos Aires. Secondary objective 1. To assess the association between the presence of aspiration and the usual degree of dyspnea in patients with COPD. 2. To assess the association between the presence of aspiration and the amount of regular annual exacerbations in patients with COPD. 3. To evaluate the association between the presence of aspiration and degree of severity according to GOLD criteria in patients with COPD. 4. 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.

Interventions

PROCEDUREFEESST

Flexible Endoscopic Evaluation of Swallowing with Sensory Testing

Sponsors

ATS MECOR (Methods in Epidemiologic, Clinical and Operations Research) Latin America program - Faculty Team
CollaboratorUNKNOWN
Hospital Italiano de Buenos Aires
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Presence of any consistence Airway AspirationBaseline (Time 0)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.

Secondary

MeasureTime frameDescription
Aspiration RiskBaseline (Time 0)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.

Countries

Argentina

Contacts

Primary ContactDiego DG Giunta, MD
diego.giunta@hospitalitaliano.org.ar+54 11 49590200
Backup ContactFernando Warley, MD
fernando.warley@hospitalitaliano.org.ar

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026