Prevalence of Respiratory Aspiration in Patients With COPD

NCT02722629 | Unknown DMC

• 1 other identifier: 2671
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

COPD; Respiratory Aspiration; COPD acute exacerbation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Aspiration Risk

  Baseline (Time 0)

Study Arms (1)

Aspiration in COPD patients

EXPERIMENTAL

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

Interventions

FEESST PROCEDURE

Flexible Endoscopic Evaluation of Swallowing with Sensory Testing

Aspiration in COPD patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \- Patients over 64 years diagnosed with chronic obstructive pulmonary disease guide GOLD criteria (FEV1 / FVC ratio post bronchodilator \<0.70)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead
• ATS MECOR (Methods in Epidemiologic, Clinical and Operations Research) Latin America program - Faculty Team: collaborator

Study Sites (1)

Hospital Italiano de Buenos Aires, Peron 4190

Buenos Aires, Buenos Aires F.D., C1199ABB, Argentina

RECRUITING

Related Publications (5)

• 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. doi: 10.1183/09031936.06.00025805. No abstract available.

  PMID: 16452599 RESULT

• Ciapponi A, Alison L, Agustina M, Demian 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.

  PMID: 24111903 RESULT

• Steidl E, Ribeiro CS, Goncalves 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-0034-1376430. Epub 2014 Nov 6.

  PMID: 25992155 RESULT

• 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: 10.7162/S1809-97772013000300007.

  PMID: 26106452 RESULT

• 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. BMC Pulm Med. 2015 Jul 8;15:69. doi: 10.1186/s12890-015-0064-5.

  PMID: 26152178 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Officials

• Hernan Benito, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

• Diego h Giunta, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

• Fernando Warley, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

• Bruno Ferreyro, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

• Federico Sala, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego DG Giunta, MD

CONTACT

+54 11 49590200; diego.giunta@hospitalitaliano.org.ar

Fernando Warley, MD

CONTACT

fernando.warley@hospitalitaliano.org.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 30, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 22, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

AR (1)