Prevalence of Respiratory Aspiration in Patients With COPD
Primary Purpose
COPD
Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
FEESST
Sponsored by
About this trial
This is an interventional screening trial for COPD focused on measuring COPD, Respiratory Aspiration, COPD acute exacerbation
Eligibility 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.
Sites / Locations
- Hospital Italiano de Buenos Aires, Peron 4190Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aspiration in COPD patients
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02722629
First Posted
March 9, 2016
Last Updated
August 19, 2016
Sponsor
Hospital Italiano de Buenos Aires
Collaborators
ATS MECOR (Methods in Epidemiologic, Clinical and Operations Research) Latin America program - Faculty Team
1. Study Identification
Unique Protocol Identification Number
NCT02722629
Brief Title
Prevalence of Respiratory Aspiration in Patients With COPD
Official Title
Prevalence of Respiratory Aspiration in Patients With COPD: Cross-sectional Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Italiano de Buenos Aires
Collaborators
ATS MECOR (Methods in Epidemiologic, Clinical and Operations Research) Latin America program - Faculty Team
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Primary objective To estimate the prevalence of respiratory aspiration in patients with COPD, in a tertiary hospital of Buenos Aires.
Secondary objective
To assess the association between the presence of aspiration and the usual degree of dyspnea in patients with COPD.
To assess the association between the presence of aspiration and the amount of regular annual exacerbations in patients with COPD.
To evaluate the association between the presence of aspiration and degree of severity according to GOLD criteria in patients with COPD.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD, Respiratory Aspiration, COPD acute exacerbation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aspiration in COPD patients
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
FEESST
Intervention Description
Flexible Endoscopic Evaluation of Swallowing with Sensory Testing
Primary Outcome Measure Information:
Title
Presence of any consistence Airway Aspiration
Description
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.
Time Frame
Baseline (Time 0)
Secondary Outcome Measure Information:
Title
Aspiration Risk
Description
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.
Time Frame
Baseline (Time 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diego DG Giunta, MD
Phone
+54 11 49590200
Ext
4806
Email
diego.giunta@hospitalitaliano.org.ar
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando Warley, MD
Email
fernando.warley@hospitalitaliano.org.ar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hernan Benito, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Diego h Giunta, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernando Warley, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno Ferreyro, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Federico Sala, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires, Peron 4190
City
Ciudad Autonoma de Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
C1199ABB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego H Giunta, MD
Phone
+54 9 11 5825-6489
Email
diego.giunta@hospitalitaliano.org.ar
First Name & Middle Initial & Last Name & Degree
Cristina M Elizondo, MD
Phone
+54 9 11 5745-8048
Email
cristina.elizondo@hospitalitaliano.org.ar
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
16452599
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. doi: 10.1183/09031936.06.00025805. No abstract available.
Results Reference
result
PubMed Identifier
24111903
Citation
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.
Results Reference
result
PubMed Identifier
25992155
Citation
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.
Results Reference
result
PubMed Identifier
26106452
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: 10.7162/S1809-97772013000300007.
Results Reference
result
PubMed Identifier
26152178
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. BMC Pulm Med. 2015 Jul 8;15:69. doi: 10.1186/s12890-015-0064-5.
Results Reference
result
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Prevalence of Respiratory Aspiration in Patients With COPD
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