Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- amplitude of displacement of thoraco-abdominal compartments
研究概览
简要总结
this study aim to evaluate wether new, non-invasive and non-contact devices such as Structured Light Plethysmography (SLP) and Sonar would be able to accurately detect and quantify diaphragm dysfunction (mono-or-bilateral) by assessing the asymmetric chest wall motion generated during spontaneous breathing as compared with a classic, standard and invasive technique.
详细描述
The measurements of chest and abdominal wall movements during quiet tidal breathing will be performed simultaneously using SLP and Sonar devices.
Subjects will be asked to sit down on a chair with their neck in a neutral position and their back as straight as possible. The SLP and the Sonar will be lined up to project the grid of light and the ultrasonic wave sonar over the participant's chest and abdomen. Data will be collected during 5 minutes of tidal breathing. The same procedure will be repeated while having the patient lying down in supine position on the same chair for 5 additional minutes. During both sessions (sitting and supine), patients will be asked to perform a gentle inspiratory capacity (IC) maneuver to better appreciate the thoraco-abdominal asymmetry and distortion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no respiratory disease
- •no neurologic disease
- •no thoracic deformation
- •Exclusion criteria
- •respiratory disease
- •neurologic disease
- •thoracic deformation
- •FOR PATIENTS
- •Inclusion Criteria:
- •patients with a suspicion of diaphragmatic dysfunction
排除标准
- •pregnant women
- •contraindications to standard procedure requiring transdiaphragmatic measurement
结局指标
主要结局
amplitude of displacement of thoraco-abdominal compartments
时间窗: 10 minutes
asymmetry of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres
次要结局
- displacement speed of thoraco-abdominal compartments(10 minutes)