A Novel Method to Measure Diaphragmatic Motion and Excursion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Time taken to measure diaphragmatic excursion
研究概览
简要总结
This study evaluates the movement of the diaphragm (which is the main muscle used for breathing). It will compare two ultrasound modalities: linear ultrasound versus curvilinear ultrasound, at measuring diaphragm motion. The proposed measurement method with linear ultrasound is novel, and will be compared against the established method with curvilinear ultrasound. The investigators hypothesize that the novel method will have several potential advantages, including: it may be easier to learn, quicker to perform, and have a lower failure rate.
详细描述
Background:
Multiple pathologies cause diaphragmatic dysfunction, including: respiratory, abdominal and neurological disease. Established clinical tests of diaphragmatic function, include: the transdiaphragmatic pressure, the maximal static inspiratory pressure, the sniff inspiratory pressure, pulmonary function tests, electromyography, a chest radiograph or fluoroscopy.
However ultrasound assessment of diaphragmatic function is a non-invasive, radiation-free technique that has gained traction in clinical practice in recent years. Several different methods have been described, that examine motion in two different areas of the diaphragm, either the zone of apposition, or the dome of the diaphragm, however no one method has emerged as the standard of care.
The current conventional technique (using B-mode or M-mode ultrasound via a phased array or curvilinear probe) in the subcostal region, has several limitations:
- It can be difficult to measure right hemi-diaphragm excursion with deep breathing, with a failure rate of up to 28% described for quantitative assessment.
- It is even more difficult to quantitatively assess left hemi-diaphragmatic excursion with deep breathing, as the spleen provides a smaller window compared to the liver window. Failure rates of 79% and 65% have been reported.
- When using M-mode, the ultrasound beam must image the diaphragmatic excursion line at a perpendicular angle, otherwise reproducibility and accuracy are adversely effected.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phase 1 Any healthy adult patient undergoing elective surgery
- •Phase 2 Any adult patient, undergoing elective upper limb surgery that involves an interscalene or supraclavicular brachial plexus block.
排除标准
- •(i) Inability to obtain an informed consent (e.g. language barrier) (ii) BMI > 35 (iii) Known pre-existing diaphragmatic dysfunction (iv) Existing lung pathology
- •Known abnormal pulmonary function tests
- •Severe pulmonary disease e.g., COPD, asthma, pulmonary fibrosis, or any other significant respiratory disease that would adversely affect diaphragm function or pulmonary function tests
- •Additional Criteria for Phase 2 Any contraindication to an interscalene or supraclavicular brachial plexus block
结局指标
主要结局
Time taken to measure diaphragmatic excursion
时间窗: 60 minutes
To measure in minutes the time taken to quantify diaphragmatic excursion from end inspiration to end expiration, and to compare the linear probe versus the curvilinear probe.
次要结局
- Normal range of values for diaphragmatic excursion using linear ultrasound(30 mins)
- Quantify and compare the reduction in diaphragmatic motion following a phrenic nerve block(2 hours)
- Success rate of measuring both the left and right hemi-diaphragmatic movement(60 mins)