The Feasibility of Continuous Bronchoscopy During Exercise in Healthy Adults in Assessing Large Airways Collapse
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility of continuous bronchoscopy during exercise (CBE): questionnaire
研究概览
简要总结
The large central airways (i.e. trachea and bronchi) act as a conduit to enable lower airway ventilation but also facilitate airway clearance during dynamic manoeuvres, such as coughing. It is becoming increasingly well recognised however, that in a significant proportion of individuals with chronic airway disease (e.g. chronic obstructive pulmonary disease-COPD or chronic asthma) and in those with an elevated body mass index (BMI), that the large airways may exhibit a tendency to excessive closure or narrowing. This large airway collapse (LAC) can be associated with exertional breathlessness and difficulty clearing airway secretions. A variety of terms have been used to describe LAC including excessive dynamic airway collapse (EDAC) or if the cartilaginous structures are involved then tracheobronchomalacia (TBM).
One clear limitation of the current approach to diagnosis is the fact that many of the 'diagnostic' tests employed, utilise static, supine measures +/- forced manoeuvres. These are somewhat physiologically flawed and differ markedly from the reality of the heightened state of airflow that develops during exertion. i.e. forced manoeuvres likely induce very different turbulent and thoracic pressure changes, in contrast to the hyperpnoea of real-life physical activity (i.e. walking or cycling). A current unanswered question is therefore, what happens to the large airway dynamic movement of healthy individuals (and ultimately patients) during real-life exercise and how does this compare with the measures taken during a forced manoeuvre, either during a bronchoscopy or during an imaging study such as CT or MRI scan.
The key aim of this study is therefore to evaluate and characterise large airway movement in a cohort of healthy adults during a real-life exercise challenge and to compare this with findings from a dynamic expiratory MRI. In order to achieve this, the investigators proposes to develop and test the feasibility of an exercise-bronchoscopy protocol.
详细描述
The large central airways (i.e. trachea and bronchi) act as a conduit to enable lower airway ventilation but also facilitate airway clearance during dynamic manoeuvres, such as coughing. It is becoming increasingly well recognised however, that in a significant proportion of individuals with chronic airway disease (e.g. chronic obstructive pulmonary disease or chronic asthma) and in those with an elevated body mass index (BMI), that the large airways may exhibit a tendency to excessive closure or narrowing. This large airway collapse (LAC) can be associated with exertional breathlessness and difficulty clearing airway secretions. A variety of terms have been used to describe LAC including excessive dynamic airway collapse (EDAC) or if the cartilaginous structures are involved then tracheobronchomalacia (TBM).
At the current time, there is considerable debate regarding the definition of LAC. Typically the 'excessive' collapse underpinning a 'diagnosis' of EDAC is defined as excessive bulging of the posterior tracheal membrane into the airway lumen during expiration without associated collapse of the cartilaginous rings, however the degree to which the trachea closes, to constitute EDAC is debated, with literature varying from >50% to >90%. Moreover, partial expiratory airways collapse (up to 50% reduction in airways cross-sectional area) can be identified in 70-80% of healthy individuals during dynamic computed tomography (CT).
One clear limitation of the current approach to diagnosis is the fact that many of the 'diagnostic' tests employed, utilise static, supine measures +/- forced manoeuvres. These are somewhat physiologically flawed and differ markedly from the reality of the heightened state of airflow that develops during exertion. i.e. forced manoeuvres likely induce very different turbulent and thoracic pressure changes, in contrast to the hyperpnoea of real-life physical activity (i.e. walking or cycling). A current unanswered question is therefore, what happens to the large airway dynamic movement of healthy individuals (and ultimately patients) during real-life exercise and how does this compare with the measures taken during a forced manoeuvre, either during a bronchoscopy or during an imaging study such as CT or MRI scan.
The key aim of this study is therefore to evaluate and characterize large airway movement in a cohort of healthy adults during a real-life exercise challenge and to compare this with findings from a dynamic expiratory MRI and MRI during exercise. In order to achieve this, the investigators propose to develop and test the feasibility of an exercise-bronchoscopy protocol.
As a clinical service, the investigators have extensive experience of evaluating movement of the upper airway and larynx during strenuous exercise. The Principal Investigator currently performs over 100 continuous laryngoscopy during exercise (CLE) tests per year, whereby a small laryngoscope is placed in the upper airway and is secured on a headgear to allow visualisation of the laryngeal and subglottic movement during exercise. i.e. whilst a subject performs running exercise. This test has an established role in patient evaluation and a proven safety record in the assessment of laryngeal closure during exercise. The research team has performed approximately 500 CLE tests in the Royal Brompton Hospital, with no serious adverse outcome.
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
- 20 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will need to be within the age range of 20-60 years old
- •have no known respiratory disease and normal spirometry
- •be able to exercise without medical reason for limitation.
排除标准
- •Subjects who have a significant comorbidity that prohibit exercise
- •have had a respiratory infection within the last month
- •known respiratory disease
- •current smokers or are pregnant.
结局指标
主要结局
Feasibility of continuous bronchoscopy during exercise (CBE): questionnaire
时间窗: 12 months
Primary outcome will be the feasibility of continuous bronchoscopy during continuous exercise in healthy adults. Feasibility will be assessed via a post CBE tolerability questionnaire. The post exercise tolerability questionnaire aims to evaluate the upper airways function during exercise and the discomfort that the participant might experience during the test. It consists of 5 questions (Part A) where the score ranges from 1 (strongly disagree) to 5 (strongly agree), and 2 questions (Part B) where the score ranges from 1 (None at all) to 10 (Unbearable amount). The total score that will confirm the feasibility of CBE should be \< 3 or \< 5, for Part A and B, respectively. The questions relate to the tolerability of the CBE test (e.g., Exercise with the camera in place cause discomfort, 1 (strongly agree) to 5 (strongly disagree).
次要结局
- Exploring the diagnostic capacity of different exercise modalities to assess LAC(12 months)
- Diagnostic capacity of CBE and MRIE(12 months)
- Comparing dynamic versus physical exertion large airway collapse in CBE and MRIE(12 months)
