Physiology and Structure of the Small Airways in Patients With Chronic Airflow Obstruction or COVID-19
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Respiratory resistance at 5Hz - 20Hz (R5-R20) (kPa/l/s) related to airtrapping as determined by quantitative CT (Expiratory phase low attenuation area <856 HU (%LAA <856 HU)
研究概览
简要总结
The purpose of this research project is to study small airways physiological function in patients with chronic obstructive lung disease or COVID-19 and explore the relationship with in-vivo microanatomical small airway structure as measured by OCT. Correlating endobronchial assessment with multiple breath nitrogen washout and impulse oscillometry will allow the characterisation of the relationship between small airway structural findings and these validated investigations. A small volume lung wash, endobronchial brushings and the collection of a limited number of endobronchial cryobiopsy samples will be performed to better understand the endobronchial environment of the small airways through inflammatory studies. Following the completion of any such work, residual samples will be stored in a "bio-bank" to enable the completion of future work. Understanding the relationship with symptom-based quality of life scoring questionnaires and a functional assessment of exercise capacity will help elucidate the clinical impact of in-vivo small airways findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 or over
- •Scheduled for bronchoscopy as part of clinical care or research protocol
- •No bleeding diathesis or therapeutic anticoagulation
- •FEV1/FVC ratio <70% or
- •Diagnosed by standard clinical methods
- •Post-bronchodilator FEV1 ≥60% predicted or COVID-19 infection or previous COVID-19 infection (confirmed as per local guidelines)
排除标准
- •Unable to provide informed consent
- •Exacerbation of obstructive airways disease or respiratory infection requiring systemic antibiotics or corticosteroids in the 6 weeks prior to enrolment unless suffering from COVID-19 infection and bronchoscopy is required for clinical reasons
- •Contra-indications to performing lung function testing
- •Aortic aneurysm >6cm
- •Unstable cardiovascular disease (unstable angina, myocardial infarction or pulmonary embolism <4 weeks prior)
- •Severe aortic stenosis
- •Pneumothorax
- •Cerebral aneurysm
- •Thoracic or abdominal surgery <4 weeks prior
- •Contra-indications to passing oesophageal balloons
- •Oesophageal ulceration or varices
- •Sinusitis, recent nasal surgery or epistaxis
结局指标
主要结局
Respiratory resistance at 5Hz - 20Hz (R5-R20) (kPa/l/s) related to airtrapping as determined by quantitative CT (Expiratory phase low attenuation area <856 HU (%LAA <856 HU)
时间窗: Baseline, pre-procedure
Impulse Oscillometry
次要结局
- Lung clearance index: LCI(Baseline, pre-procedure)
- Residual volume: RV (L)(Baseline, pre-procedure)
- Functional residual capacity by MBNW: FRCgas (L)(Baseline, pre-procedure)
- Ventilation heterogeneity conducting airways: Scond (L/s)(Baseline, pre-procedure)
- Airway mean luminal diameter (Dmean)(Baseline, during the procedure)
- Respiratory reactance at 5Hz: X5 (kPa/l/s)(Baseline, pre-procedure)
- Ventilation heterogeneity acinar airways: Sacin (L/s)(Baseline, pre-procedure)
- Forced vital capacity: FVC (L)(Baseline, pre-procedure)
- Total lung capacity: TLC (L)(Baseline, pre-procedure)
- Modified MRC dyspnoea score(Baseline, pre-procedure)
- Airway inner lumen area (Ai)(Baseline, during the procedure)
- Airway wall area (Aw), airway wall percentage (Aw%) as determined by [Aw/(Ai + Aw) × 100%](Baseline, during the procedure)
- Air trapping - expiratory phase low attenuation area <856 HU (%LAA <856 HU)(Baseline, pre-procedure)
- Asthma-related Quality of Life Questionnaire (AQLQ) (if asthmatic)(Baseline, pre-procedure)
- Reactance area: Ax (kPa/l/s)(Baseline, pre-procedure)
- Forced expiratory volume in 1 second: FEV1 (L)(Baseline, pre-procedure)
- Functional residual capacity by plethysmography: FRCpleth (L)(Baseline, pre-procedure)
- St George's Respiratory Questionnaire Score(Baseline, pre-procedure)
- Asthma Control Questionnaire (ACQ) (if asthmatic)(Baseline, pre-procedure)
- 6-minute walk distance (m)(Baseline, pre-procedure)