Prevalence of Respiratory Aspiration in Patients With COPD
- Conditions
- COPD
- Interventions
- Procedure: FEESST
- Registration Number
- NCT02722629
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 330
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Aspiration in COPD patients FEESST 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.
- Primary Outcome Measures
Name Time Method Presence of any consistence Airway Aspiration 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
Name Time Method Aspiration Risk 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.
Trial Locations
- Locations (1)
Hospital Italiano de Buenos Aires, Peron 4190
🇦🇷Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina