Dynamic Chest X-ray With Simultaneous Spirometry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Correlation between Dynamic chest X-ray (DCR) metrics And Spirometry metrics in people with Cystic fibrosis and those with no underlying respiratory conditions
研究概览
简要总结
Dynamic chest X-ray (DCR) is a novel radiographic technique that enables us to visualise the movement of the chest and lungs in real-time by recording a series of x-ray images over 10-20 second interval. DCR provides an assessment of structures involved in respiration over a time period and could therefore provide us with insights into respiratory function. It may be possible that relating DCR to conventional breathing tests allows it to be used as a surrogate tool to measure lung function. Alternatively, it may provide different parameters of lung function which don't directly correlate with conventional testing, but are of themselves clinically relevant.
Cystic fibrosis (CF) is a genetic condition that results in the body producing thick , dehydrated secretions. It is usually characterised by a cycle of recurring lung infections and inflammation resulting in progressive lung damage. A key clinical investigation for people with cystic fibrosis (pwCF), and other chest conditions, is a spirometry breathing test. Despite spirometry's fundamental role in chest medicine it can be poorly tolerated.
In order to evaluate the utility of DCR as a tool for assessing lung function, it is important to be able to compare it to currently available pulmonary function tests such as spirometry. Previous studies have compared sequential lung function testing to DCR images; however, there may be significant variability in 2 separate manoeuvres as they are effort and technique dependent (i.e. when performing a DCR followed by spirometry or vice versa). Currently, there have been no studies that compare DCR with a simultaneous lung function test such as spirometry.
This observational, prospective, non-randomised, single centre , pilot study aims to address this issue by performing simultaneous spirometry and DCR to establish how DCR compares with spirometry in a healthy population of individuals. The investigators would seek to also perform the DCR with simultaneous spirometry in a cohort of pwCF, allowing for comparison between the two groups. Furthermore DCR imaging has been part of the annual review process for pwCF at Liverpool Heart and Chest Hospital since 2019. The study investigators therefore intend to review how changes in DCR metrics over time relate to changes in other key clinical markers of pwCF, such as spirometry. A questionnaire on patient experiences of DCR will be provided to study participants to be filled in after imaging acquisition.
详细描述
Dynamic chest X-ray (DCR) records images of the chest in motion in a 'recording' over 10-20 seconds. This is essentially a video x-ray of the chest and associated structures involved in breathing. The images acquired by the DCR can be processed using computer algorithm and key quantitative measures derived (such as diaphragm movement speed and changes in lung field area). Due to the way the X-ray is acquired, this is relatively lower radiation than other video caption imaging available (such as fluoroscopy). The time component of the imaging (vs static imaging) also opens up possibilities for clinical utilisation beyond imaging techniques that are already available without losing clinical information that a conventional static x-ray provides. The direct visualization of the chest and lung field in motion may therefore provide clinically relevant information about respiratory function. It may be possible that relating DCR to conventional lung function testing allows it to be used as a surrogate tool for assessing pulmonary function. Alternatively, it may provide different parameters of lung function that don't directly correlate with conventional testing but are of themselves clinically relevant.
Cystic fibrosis (CF) is an autosomal recessive genetic condition resulting in viscid, dehydrated luminal secretions. It has multi-system consequences but is usually characterised by a cycle of recurring lung infections and inflammation resulting in progressive lung damage. A key clinical investigation for people with cystic fibrosis (pwCF), as well as many other chest conditions, is a spirometry breathing test. Despite this spirometry can be poorly tolerated in individuals with underlying respiratory conditions. Patient factors combined with the ease and speed of acquiring DCR may mean it is better tolerated than conventional pulmonary function techniques such as spirometry. No previous studies have directly compared DCR with simultaneous breathing tests (such as spirometry). This is important as there can be significant variability in two different breathing manoeuvres such as used in breathing tests like spirometry. This means direct comparison is difficult when the tests are performed sequentially.
This study aims to address this by performing simultaneous spirometry and DCR to establish how DCR compares with spirometry in a healthy population of individuals. Study investigators also aim to perform DCR with simultaneous spirometry in a cohort of people with cystic fibrosis (pwCF), this would allow for comparison between the two groups. Furthermore the DCR has been part of Liverpool Heart and Chest Hospital's (LHCH) annual review process for pwCF since 2019. Study investigators therefore intend to review how changes in DCR metrics over time relate to other key clinical parameters for pwCF such as spirometry values. A questionnaire on patient experiences of DCR will be provided to patients after completion of the examinations, to be filled in at the time of investigation acquisition.
Principal research objective: to understand how DCR relates to a conventional assessment of lung function testing in the form of spirometry in both pwCF and those with no underlying lung health problems.
Secondary research objective: to understand how the relationship between metrics recorded by DCR imaging over time and key clinical markers of CF recorded in the annual review process, such as lung function recorded by spirometry.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 50 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Correlation between Dynamic chest X-ray (DCR) metrics And Spirometry metrics in people with Cystic fibrosis and those with no underlying respiratory conditions
时间窗: During the test (simultaneous acquisition of dynamic chest X-ray and Spirometry)
DCR metrics as calculated by software analysis of DCR imaging. This includes: projected lung area, diaphragm movement and signal density of the image. Spirometry metrics: e.g forced expiratory volume at one second (FEV1) and forced vital capacity (FVC)
次要结局
- Correlation between DCR metrics and Spirometry metrics over time, as recorded in annual review CF clinic attendance (non-simultaneous)(Day of annual review attendance up to 48 months prior (first DCR acquisition 2019))
