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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	29 August 2016
Main ID:	NCT02722629
Date of registration:	09/03/2016
Prospective Registration:	Yes
Primary sponsor:	Hospital Italiano de Buenos Aires
Public title:	Prevalence of Respiratory Aspiration in Patients With COPD
Scientific title:	Prevalence of Respiratory Aspiration in Patients With COPD: Cross-sectional Study
Date of first enrolment:	June 2016
Target sample size:	330
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02722629
Study type:	Interventional
Study design:	Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Phase:	N/A

Countries of recruitment
Argentina

Contacts

Name:	Bruno Ferreyro, MD
Address:
Telephone:
Email:
Affiliation:	Hospital Italiano de Buenos Aires

Name:	Federico Sala, MD
Address:
Telephone:
Email:
Affiliation:	Hospital Italiano de Buenos Aires

Name:	Diego DG Giunta, MD
Address:
Telephone:	+54 11 49590200
Email:	diego.giunta@hospitalitaliano.org.ar
Affiliation:

Name:	Diego h Giunta, MD
Address:
Telephone:
Email:
Affiliation:	Hospital Italiano de Buenos Aires

Name:	Diego H Giunta, MD
Address:
Telephone:	+54 9 11 5825-6489
Email:	diego.giunta@hospitalitaliano.org.ar
Affiliation:

Name:	Fernando Warley, MD
Address:
Telephone:
Email:
Affiliation:	Hospital Italiano de Buenos Aires

Name:	Hernan Benito, MD
Address:
Telephone:
Email:
Affiliation:	Hospital Italiano de Buenos Aires

Key inclusion & exclusion 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.

Age minimum: 65 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

COPD

Intervention(s)

Procedure: FEESST

Primary Outcome(s)

Presence of any consistence Airway Aspiration [Time Frame: Baseline (Time 0)]

Secondary Outcome(s)

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

Secondary ID(s)

2671

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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