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Prevalence of Respiratory Aspiration in Patients With COPD

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ClinicalTrials.gov Identifier: NCT02722629
Recruitment Status : Unknown
Verified March 2016 by Hospital Italiano de Buenos Aires.
Recruitment status was:  Recruiting
First Posted : March 30, 2016
Last Update Posted : August 22, 2016
Sponsor:
Collaborator:
ATS MECOR (Methods in Epidemiologic, Clinical and Operations Research) Latin America program - Faculty Team
Information provided by (Responsible Party):
Hospital Italiano de Buenos Aires

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.

Condition or disease Intervention/treatment Phase
COPD Procedure: FEESST Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Prevalence of Respiratory Aspiration in Patients With COPD: Cross-sectional Study
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: 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.
Procedure: FEESST
Flexible Endoscopic Evaluation of Swallowing with Sensory Testing




Primary Outcome Measures :
  1. Presence of any consistence Airway Aspiration [ Time Frame: Baseline (Time 0) ]

    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 :
  1. Aspiration Risk [ Time Frame: Baseline (Time 0) ]

    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.




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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722629


Contacts
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Contact: Diego DG Giunta, MD +54 11 49590200 ext 4806 diego.giunta@hospitalitaliano.org.ar
Contact: Fernando Warley, MD fernando.warley@hospitalitaliano.org.ar

Locations
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Argentina
Hospital Italiano de Buenos Aires, Peron 4190 Recruiting
Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1199ABB
Contact: Diego H Giunta, MD    +54 9 11 5825-6489    diego.giunta@hospitalitaliano.org.ar   
Contact: Cristina M Elizondo, MD    +54 9 11 5745-8048    cristina.elizondo@hospitalitaliano.org.ar   
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
ATS MECOR (Methods in Epidemiologic, Clinical and Operations Research) Latin America program - Faculty Team
Investigators
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Principal Investigator: 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

Publications of Results:
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Responsible Party: Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT02722629     History of Changes
Other Study ID Numbers: 2671
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Hospital Italiano de Buenos Aires:
COPD
Respiratory Aspiration
COPD acute exacerbation

Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes