Prevalence of Respiratory Aspiration in Patients With COPD

NCT ID: NCT02722629

Last Updated: 2016-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-07-31

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

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.

Conditions

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COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Aspiration in COPD patients

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.

Group Type EXPERIMENTAL

FEESST

Intervention Type PROCEDURE

Flexible Endoscopic Evaluation of Swallowing with Sensory Testing

Interventions

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FEESST

Flexible Endoscopic Evaluation of Swallowing with Sensory Testing

Intervention Type PROCEDURE

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ATS MECOR (Methods in Epidemiologic, Clinical and Operations Research) Latin America program - Faculty Team

UNKNOWN

Sponsor Role collaborator

Hospital Italiano de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hernan Benito, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Diego h Giunta, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Fernando Warley, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Bruno Ferreyro, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Federico Sala, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Locations

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Hospital Italiano de Buenos Aires, Peron 4190

Buenos Aires, Buenos Aires F.D., Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Diego DG Giunta, MD

Role: CONTACT

+54 11 49590200 ext. 4806

Fernando Warley, MD

Role: CONTACT

Facility Contacts

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Diego H Giunta, MD

Role: primary

+54 9 11 5825-6489

Cristina M Elizondo, MD

Role: backup

+54 9 11 5745-8048

References

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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.

Reference Type RESULT
PMID: 16452599 (View on PubMed)

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.

Reference Type RESULT
PMID: 24111903 (View on PubMed)

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.

Reference Type RESULT
PMID: 25992155 (View on PubMed)

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.

Reference Type RESULT
PMID: 26106452 (View on PubMed)

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.

Reference Type RESULT
PMID: 26152178 (View on PubMed)

Other Identifiers

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2671

Identifier Type: -

Identifier Source: org_study_id

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