COPDNCT02722629
Prevalence of Respiratory Aspiration in Patients With COPD
A study testing FEESST in people with COPD, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- COPD
- What is being tested?
- FEESST
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteArgentina
- Study dates
- Jun 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over 64 years diagnosed with chronic obstructive pulmonary disease guide GOLD criteria (FEV1 / FVC ratio post bronchodilator <0.70)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Fernando Warley, MD contact
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires, Peron 4190
Buenos Aires, Buenos Aires F.D., C1199ABB
Diego H Giunta, MD, +54 9 11 5825-6489, diego.giunta@hospitalitaliano.org.ar
Cristina M Elizondo, MD, +54 9 11 5745-8048, cristina.elizondo@hospitalitaliano.org.ar
About this study
Official title: Prevalence of Respiratory Aspiration in Patients With COPD: Cross-sectional Study
The aim of the study is to estimate the prevalence of respiratory aspiration in patients with COPD, in a tertiary hospital of Buenos Aires.
Read the 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.
- Conditions
- COPD
- Being tested
- FEESST
- Keywords
- COPD, Respiratory Aspiration, COPD acute exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEESSTProcedure or surgery
Flexible Endoscopic Evaluation of Swallowing with Sensory Testing
| Study group | Role | What they receive |
|---|---|---|
| Aspiration in COPD patients | Experimental | 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. Receives: Procedure: FEESST |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Time 0)
Secondary outcomes (1)
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.
Measured: Baseline (Time 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- ATS MECOR (Methods in Epidemiologic, Clinical and Operations Research) Latin America program - Faculty Team
- Responsible party
- Sponsor
- Investigators
- Hernan Benito, MD, Principal investigator, Hospital Italiano de Buenos AiresDiego h Giunta, MD, Principal investigator, Hospital Italiano de Buenos AiresFernando Warley, MD, Principal investigator, Hospital Italiano de Buenos AiresBruno Ferreyro, MD, Principal investigator, Hospital Italiano de Buenos AiresFederico Sala, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722629
- Sponsor's protocol ID
- 2671
- Status last verified
- Mar 2016
- First submitted
- 9 Mar 2016
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 16452599Ciapponi 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.
PubMed 24111903Steidl 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.
PubMed 25992155Macri 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.
PubMed 26106452Yamauchi 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.
PubMed 26152178
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Respiratory Aspiration in Patients With COPD: Cross-sectional Study
- ClinicalTrials.gov ID
- NCT02722629
- Acronym / sponsor ID
- 2671
- Conditions
- COPD
- Keywords
- COPD, Respiratory Aspiration, COPD acute exacerbation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- ATS MECOR (Methods in Epidemiologic, Clinical and Operations Research) Latin America program - Faculty Team
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aspiration in COPD patients | Experimental | Procedure: FEESSTAll COPD patient will be evaluated systematically by FEESST (Flexible Endoscopic Evaluation of Swallowing with Sensory Testing) with direct evaluation of aspiration by direct observation. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients over 64 years diagnosed with chronic obstructive pulmonary disease guide GOLD criteria (FEV1 / FVC ratio post bronchodilator <0.70)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEESSTFlexible Endoscopic Evaluation of Swallowing with Sensory Testing | Procedure or surgery | Aspiration in COPD patients |
Primary outcome
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.
1 secondary outcome
Aspiration Risk
Time frame: Baseline (Time 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Results publication: PubMed 16452599Lopez 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 publication: PubMed 24111903Ciapponi 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 publication: PubMed 25992155Steidl 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 publication: PubMed 26106452Macri 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 publication: PubMed 26152178Yamauchi 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Warley, MD contact
Hernan Benito, MD principal investigator
Hospital Italiano de Buenos Aires
Diego h Giunta, MD principal investigator
Hospital Italiano de Buenos Aires
Fernando Warley, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FEESST in people with COPD, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego DG Giunta, MD (+54 11 49590200 ext. 4806, diego.giunta@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of any consistence Airway Aspiration (time frame: Baseline (Time 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722629, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.