Functional Lung Imaging in Patients With Respiratory Compromise Undergoing Endobronchial Valve Placement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The objective of the current investigation is to determine whether XV technology can assist in determining lobar selection, indicators of success, or response-related clinical outcomes with BLVR.
研究概览
简要总结
Bronchoscopic lung volume reduction (BLVR) using endobronchial valves is effective in improving quality of life in patients suffering from emphysema. BLVR treatment in advanced emphysema requires targeted segmental or sub-segmental placement of endobronchial valves (EBV) to achieve total lobar occlusion to induce effective lobar volume reduction. BLVR procedure success rate declines in patients with incomplete lobar fissure integrity due to the potential for collateral ventilation to circumvent EBV lobar occlusion. Current methods that assess lobar collateral ventilation as a correlate of fissure integrity are imperfect, resulting in a significant percentage of patients having equivocal assessment, leading to suboptimal selection of patients and potential for inappropriate selection of patients for BLVR. Additionally, methods used to select the target lobe for EBV placement predominately rely on the extent of emphysematous destruction. There is also a need to select based on the extent of physiological disturbance at the lobar level. Distribution of ventilation or regional ventilation heterogeneity may be associated with collateral ventilation. Therefore, in this study we wish to quantify lobar distribution of ventilation and ventilation heterogeneity in patients undergoing investigation for BLVR to determine the additive contribution of functional lung imaging for assessing lobar physiological derangement and suitability for EBV treatment.
详细描述
Approach: A novel functional lung imaging, X-ray Velocimetry (XV) technology images the motion of the lungs, determines airway volumes and measures regional lung ventilation during spontaneous breathing. Specific measurements of lobar volume at end inspiration, expiration and the tidal breathing changes, inspiratory and expiratory lobar flow and estimation of airway flow resistance using x-ray velocimetry. These variables will be used to explore indices related to collateral ventilation by comparing time-volume changes based on segmentation and differential residual. The performance of XV has been assessed in cohort and case series of patients undergoing therapy for cancer, demonstrating changes in ventilation distribution and heterogeneity. The objective of the current investigation is to determine whether XV technology can assist in determining lobar selection, indicators of success, or response-related clinical outcomes with BLVR.
Scope: Examine ventilation distribution and heterogeneity using XV functional lung imaging analysis in moderate to severe COPD undergoing evaluation for BLVR.
Aims: 1) Assess the applicability of XV ventilation distribution and heterogeneity for BLVR candidate screening compared to conventional tools of quantitative HRCT and ventilation perfusion scanning.
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Identify characteristics of lobar ventilation distribution and ventilation heterogeneity in candidates being assessed for BLVR.
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Determine whether if there is an association between functional lung imaging data and clinical status (6MWD, St George's Questionnaire, CAT, mMRC (Modified Medical Research Council) Dyspnea Scale).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Emphysema
- •Undergoing evaluation and planned treatment with BLVR
- •Adults, 40 years of age and older
- •Consents to functional lung imaging evaluation
- •Access to previous chest CT as part of the clinical workup for BLVR
排除标准
- •Known contraindication to BLVR
- •Currently receiving mechanical ventilation, intensive or other critical care
- •Pregnant women
- •Contraindication to ionizing radiation
结局指标
主要结局
The objective of the current investigation is to determine whether XV technology can assist in determining lobar selection, indicators of success, or response-related clinical outcomes with BLVR.
时间窗: functional lung imaging and software analysis will be available after the procedure
Functional lung imaging analysis in endobronchial valve placement
次要结局
未报告次要终点