Prevalence of Respiratory Aspiration in Patients With COPD

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02722629
• Other study ID #: 2671
• Status: Recruiting
• Phase: N/A
• First received: March 9, 2016
• Last updated: August 19, 2016
• Start date: June 2016
• Est. completion date: July 2017

Study information

• Verified date: March 2016
• Source: Hospital Italiano de Buenos Aires
• Contact: Diego DG Giunta, MD
• Phone: +54 11 49590200
• Email: diego.giunta[@]hospitalitaliano.org.ar
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• COPD
• Respiratory Aspiration

Intervention

Procedure:
• FEESST
Flexible Endoscopic Evaluation of Swallowing with Sensory Testing

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires, Peron 4190	Ciudad Autonoma de Buenos Aires	Capital Federal

Sponsors (2)

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

Country where clinical trial is conducted

Argentina, 

References & Publications (5)

Ciapponi A, Alison L, Agustina M, Demián G, Silvana C, Edgardo S. The epidemiology and burden of COPD in Latin America and the Caribbean: systematic review and meta-analysis. COPD. 2014 Jun;11(3):339-50. doi: 10.3109/15412555.2013.836479. Epub 2013 Oct 10 — View Citation

Lopez AD, Shibuya K, Rao C, Mathers CD, Hansell AL, Held LS, Schmid V, Buist S. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J. 2006 Feb;27(2):397-412. — View Citation

Macri MR, Marques JM, Santos RS, Furkim AM, Melek I, Rispoli D, de Alencar Nunes MC. Clinical and fiberoptic endoscopic assessment of swallowing in patients with chronic obstructive pulmonary disease. Int Arch Otorhinolaryngol. 2013 Jul;17(3):274-8. doi: — View Citation

Steidl E, Ribeiro CS, Gonçalves BF, Fernandes N, Antunes V, Mancopes R. Relationship between Dysphagia and Exacerbations in Chronic Obstructive Pulmonary Disease: A Literature Review. Int Arch Otorhinolaryngol. 2015 Jan;19(1):74-9. doi: 10.1055/s-0034-137 — View Citation

Yamauchi Y, Yasunaga H, Matsui H, Hasegawa W, Jo T, Takami K, Fushimi K, Nagase T. Comparison of clinical characteristics and outcomes between aspiration pneumonia and community-acquired pneumonia in patients with chronic obstructive pulmonary disease. BM — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No