NCT00966459已完成不适用
Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in COPD Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To obtain patient specific geometries of the central and peripheral small airways
研究概览
简要总结
In this study, 20 COPD patients will undergo a high-resolution/multi slice CT scan and lung function tests to obtain patient specific geometries of the central and peripheral small airways and patient specific boundary conditions.
With Computational Fluid Dynamics (CFD), the investigators will be able to reconstruct the geometry and measure the resistance of the peripheral airways.
In a later stage, CFD will be used to simulate the reaction of the airways on various inhalation medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented COPD based on the following criteria:
- •Smoking history of at least 10 pack-years.
- •Decreased Tiffeneau index (FEV1/(F)VC < 0.70).
- •Patients aged ≥ 40 years.
- •Patients should present moderate to very severe COPD with an FEV1 < 80% of predicted (GOLD 2, 3 and 4).
- •Patients should be treated according to GOLD guidelines.
- •Maintained on stable respiratory medications for 4 weeks prior to visit 1
- •Able to perform lung function tests.
排除标准
- •Patients below the age of
- •Patients who are pregnant or are breast-feeding.
- •A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
- •BMI > 35 kg/m².
- •Patients treated with BiPAP or CPAP.
- •Known active tuberculosis.
- •A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
- •A history of thoracotomy with pulmonary resection.
- •Active or untreated malignancy.
研究组 & 干预措施
1
Other
干预措施: Computed Tomography (Procedure)
结局指标
主要结局
To obtain patient specific geometries of the central and peripheral small airways
To obtain patient specific boundary conditions
次要结局
- To measure the resistance of the peripheral airways
- To measure the reaction of the airways on various inhalation medications
研究者
研究点 (1)
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