Prevalence of Respiratory Aspiration in Patients With COPD

Hospital Italiano de Buenos Aires

Status: Unknown

Conditions: COPD

Treatments: Procedure: FEESST

Study type: Interventional

Funder types: Other

Identifiers

NCT02722629

2671

Details and patient eligibility

About

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

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

330 participants in 1 patient group

Aspiration in COPD patients

Experimental group

Description:

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.

Treatment:

Procedure: FEESST