Tidal Breathing Patterns Measured by Thora-3DI™ Structured Light Plethysmography for Evaluation of Severity of Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Correlation between SLP parameters with lung Function parameters measured by spirometry and body box plethysmography ( FEV1; FEV1/FVC; TLC and RV)
研究概览
简要总结
To demonstrate differences in tidal breathing patterns measured by SLP(Structured Light Plethysmography) between healthy subjects and COPD (chronic obstructive pulmonary disease). The correlation between SLP parameters and standard lung function parameters measured by body box and spirometry will also be assessed. Trends in SLP breathing patterns between the different GOLD (Global Initiative for Chronic Obstructive Lung Disease) stages of COPD, and between those and healthy subjects, will be investigated to assess whether SLP can detect differences between groups.
详细描述
Structured light plethysmography (SLP) is a novel, non-contact method for assessing quiet 'tidal' breathing. A number of studies have reported the effects of conditions such as chronic obstructive pulmonary disease (COPD) on tidal breathing patterns, and a previous study has shown that SLP is able to detect differences in ten tidal breathing patterns between healthy subjects and patients with COPD. In this present study, the investigators will aim to confirm the previous findings and also to examine the relationship between SLP tidal breathing parameters and traditional measurements of lung function measured by spirometry and body box plethysmograph. The correlation between SLP parameters with lung Function parameters measured by spirometry and body box plethysmography: forced expiratory volume in one second (FEV1); Forced vital capacity (FVC), FEV1/FVC (forced expiratory volume in one second/forced vital capacity); total lung capacity (TLC) and residual volume (RV). Trends in tidal breathing patterns between varying severities of COPD (based on the (Global initiative for lung disease (GOLD) grading system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range 18-80 years,
- •BMI range 18-40 kg/m2
- •Patients diagnosed, or suspected, with COPD or normal subjects with no previous or current diagnosis of respiratory disease
排除标准
- •Patient unable to sit in an upright position for required period of time
- •Patients with significant co morbidities (assessed by the clinician at screening only):
- •Significant unilateral lung disease e.g. pneumonectomy
- •Chest wall or spinal deformity e.g. scoliosis
- •Obstructive sleep apnea (OSA), Apnoea hypopnoea index > 30 (if known)
- •Inability to consent/comply with trial protocol
- •Presence of an acute disease process that might interfere with test performance, e.g. Nausea, vomiting, persistent coughing)
研究组 & 干预措施
Normal Control
Participants with no diagnosis of respiratory disease between the ages of 0 and 80 whose breathing will be measured using Thora-3Di structured light plethysmography, body plethysmography and spirometry.
干预措施: Thora-3Di (Device)
Normal Control
Participants with no diagnosis of respiratory disease between the ages of 0 and 80 whose breathing will be measured using Thora-3Di structured light plethysmography, body plethysmography and spirometry.
干预措施: Body Plethysmography (Device)
Normal Control
Participants with no diagnosis of respiratory disease between the ages of 0 and 80 whose breathing will be measured using Thora-3Di structured light plethysmography, body plethysmography and spirometry.
干预措施: Spirometry (Device)
COPD Patients
Participants with chronic obstructive pulmonary disease between the ages of 0 and 80 whose breathing will be measured using Thora-3Di structured light plethysmography, body plethysmography and spirometry.
干预措施: Thora-3Di (Device)
COPD Patients
Participants with chronic obstructive pulmonary disease between the ages of 0 and 80 whose breathing will be measured using Thora-3Di structured light plethysmography, body plethysmography and spirometry.
干预措施: Body Plethysmography (Device)
COPD Patients
Participants with chronic obstructive pulmonary disease between the ages of 0 and 80 whose breathing will be measured using Thora-3Di structured light plethysmography, body plethysmography and spirometry.
干预措施: Spirometry (Device)
结局指标
主要结局
Correlation between SLP parameters with lung Function parameters measured by spirometry and body box plethysmography ( FEV1; FEV1/FVC; TLC and RV)
时间窗: Baseline
SLP breathing parameters ratios derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing correlated with lung function measured by body plethysmography and spirometry
Difference in SLP derived Phase (measured in degrees) between Patients and Healthy Subjects
时间窗: Baseline
SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing that describes the contribution of a region of the thoracoabdominal wall to total displacement
Difference in SLP Breath Timing indices measured in seconds and between Patients and Healthy Subjects
时间窗: Baseline
SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing
Difference in SLP derived Relative Contribution (measured in %) between Patients and Healthy Subjects
时间窗: Baseline
SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing that describes the contribution of a region of the thoracoabdominal wall to total displacement
Difference in SLP derived displacement rate derived parameters (measured in distance per second) between Patients and Healthy Subjects
时间窗: Baseline
SLP breathing parameters derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing
Difference in SLP displacement rate derived ratios between Patients and Healthy Subjects (measured in distance per second) between Patients and Healthy Subjects
时间窗: Baseline
SLP breathing parameters ratios derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing
次要结局
- The trends in tidal breathing patterns between varying severities of COPD (based on the GOLD grading system).(Baseline)