Risk Factors for Re-exacerbation After a Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- The relationship between change in inspiratory capacity(IC), from admission with an exacerbation of COPD to hospital discharge, and the risk of 30-day and 90-day re-exacerbation is reduced.
研究概览
简要总结
The purpose of this study is to determine whether the investigators can predict which patients are at risk of a re-exacerbation of COPD within 30 and 90 days using changes in lung capacity during the initial exacerbation.
详细描述
Patients admitted to hospital with an acute exacerbation of COPD will be approached to participate in the study.
The investigators will analyse changes in lung capacity (through measurement of spirometry and inspiratory capacity) and physical activity level over the first three days of admission, at discharge and at a day 30 follow-up visit. The investigators will record quality of life and symptom scores at these time points and again at a day 90 telephone visit. Data relating to the patients overall health status -disease severity, co-morbidity, cognition, psychological status, home environment and adherence to inhaled medication will be collected. The investigators will look for any relationship between these changes and a further exacerbations within 30 and 90 days.
The central hypothesis of this proposal is that the clinical course following an exacerbation of COPD may be monitored through measurement of inspiratory capacity(IC), a marker of lung hyperinflation. Resolution of an exacerbation is related to an increase in inspiratory capacity above a threshold level of improvement, after which the risk of re-exacerbation within the subsequent 30 and 90 days is low. The investigators will assess the accuracy of IC as a predictor of exacerbation and the feasibility of measuring IC during the early stages of a COPD exacerbation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Within 72 hours of admission with an Acute Exacerbation of COPD (AE COPD) defined as "an acute change in a patient's baseline dyspnoea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in therapy" as per ATS/ERS consensus guidelines[ ] where "a change in therapy" includes the following: Prescription of antibiotics and / or systemic steroids
- •Diagnosis of COPD based on GOLD criteria
- •Able to give informed consent
- •Willing to participate in the study
排除标准
- •Admission reason other than AE COPD or breathlessness primarily caused by another pathology
- •Already enrolled in the study
- •Receiving palliative care
- •Severe cognitive impairment or psychological disorder that results in inability to give informed consent or complete investigations required for the study
- •Physical impairment resulting in inability to complete physiological tests
结局指标
主要结局
The relationship between change in inspiratory capacity(IC), from admission with an exacerbation of COPD to hospital discharge, and the risk of 30-day and 90-day re-exacerbation is reduced.
时间窗: From admission to 90 days from hospitalisation with an exacerbation
次要结局
- Relationship between changes in IC and respiratory symptoms(From admission to 30 days from hospitalisation with an exacerbation)
- Relationship between changes in Forced Vital Capacity and respiratory symptoms(From admission to 30 days from hospitalisation with an exacerbation)
- Relationship between patient factors and subsequent exacerbation(90 days from hospitalisation with an exacerbation)
- Relationship between changes in Forced Expiratory Volume in 1 second (FEV1) and respiratory symptoms(From admission to 30 days from hospitalisation with an exacerbation)
- Relationship between change in FVC and quality of life scores(From admission to 30 days from hospitalisation with an exacerbation)
- Sensitivity of inspiratory capacity (IC) measured with a bedside portable spirometer and by the gold standard body plethysmography(Day 3-7 of hospital admission)
- Relationship between change in IC and quality of life scores(From admission to 30 days from hospitalisation with an exacerbation)
- Relationship between change in IC and gait speed(From admission to 30 days from hospitalisation with an exacerbation)
- Relationship between change in FVC and gait speed(From admission to 30 days from hospitalisation with an exacerbation)
- Sensitivity of vital capacity measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory(Day 3-7 of hospital admission)
- Relationship between change in FEV1 and quality of life scores(From admission to 30 days from hospitalisation with an exacerbation)
- Relationship between change in FEV1 and gait speed(From admission to 30 days from hospitalisation with an exacerbation)
- Sensitivity of FEV1 measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory(Day 3-7 of hospital admission)
- Time to re-exacerbation(90 days from hospitalisation with an exacerbation)
- Change in vital capacity during an exacerbation and its relationship to re-exacerbation(At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation)
- Change in FEV1 during an exacerbation and its relationship to re-exacerbation(At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation)
- Relationship between Exacerbation factors and re-exacerbation(90 days from hospitalisation with an exacerbation)
- Relationship between Social and Environmental factors and subsequent exacerbation(90 days from hospitalisation with an exacerbation)
研究者
Professor Richard Costello
Professor Richard W Costello
Beaumont Hospital