跳至主要内容
临床试验/NCT02722629
NCT02722629Unknown不适用

Prevalence of Respiratory Aspiration in Patients With COPD: Cross-sectional Study

Hospital Italiano de Buenos Aires2 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
330
试验地点
2
主要终点
Presence of any consistence Airway Aspiration

研究概览

简要总结

The aim of the study is to estimate the prevalence of respiratory aspiration in patients with COPD, in a tertiary hospital of Buenos Aires.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Presence of any consistence Airway Aspiration

时间窗: 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.

次要结局

  • Aspiration Risk(Baseline (Time 0))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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