Prevalence of Respiratory Aspiration in Patients With COPD
NCT ID: NCT02722629
Last Updated: 2016-08-22
Study Results
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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UNKNOWN
NA
330 participants
INTERVENTIONAL
2016-06-30
2017-07-31
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
SCREENING
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.
FEESST
Flexible Endoscopic Evaluation of Swallowing with Sensory Testing
Interventions
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FEESST
Flexible Endoscopic Evaluation of Swallowing with Sensory Testing
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
65 Years
ALL
No
Sponsors
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ATS MECOR (Methods in Epidemiologic, Clinical and Operations Research) Latin America program - Faculty Team
UNKNOWN
Hospital Italiano de Buenos Aires
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
Other Identifiers
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2671
Identifier Type: -
Identifier Source: org_study_id
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