Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion (COSINE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal
研究概览
简要总结
The aim of this study is to better understand the relationship between pleural effusions and breathlessness in patients with unilateral pleural effusions and breathlessness who require pleural fluid removal for its management.
详细描述
This study will involve 124 adult patients who are breathlessness with pleural effusions. They will be recruited from a single UK centre over an 18-month period.
After being informed about the study, all patients giving written informed consent will undergo a baseline assessment when they first come to have their fluid drained. The investigators will record information about them and their disease. The investigators will take measurements of their breathlessness, their breathing muscles, and the electrical activity from the brain to those muscles. These will be taken at the start and end of drainage, as well as 1 day and 7 days after. The investigators will use this information to look for links between the effect of pleural effusions and its removal on the electrical activities of the breathing muscles and patients' breathlessness.
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
- 否
入选标准
- •Age 18 years or above
- •Has a unilateral pleural effusion AND
- •require thoracocentesis OR
- •chest drain insertion (main study only) OR
- •has an IPC in situ (main study only)
排除标准
- •Inability to consent
- •Any contraindications to the proposed pleural procedure
- •Haemodynamic or clinical instability that precludes from the safe completion of required pre-procedural measurements
- •Inability to identify surface landmarks for surface EMG electrode placement
- •Past medical history of diaphragmatic paralysis (diaphragm sub study only)
结局指标
主要结局
Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal
时间窗: 24 hours
VAS dyspnoea score
Neural respiratory drive (as measured by surface parasternal EMG) at 24 hours post pleural fluid removal
时间窗: 24 hours
Neural respiratory drive index (as measured by surface parasternal EMG)
次要结局
- Contralateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.(peri-procedural)
- The effect on exercise capacity of pleural fluid removal.(pre procedure, immediately post procedure, 1 day and 7 days)
- Neural respiratory drive (as measured by surface diaphragm EMG) of the ipsilateral hemidiaphragm following thoracocentesis(peri-procedural)
- Neural respiratory drive (as measured by surface diaphragm EMG) of the contralateral hemidiaphragm following thoracocentesis(peri-procedural)
- Patient reported breathlessness (as measured by VAS dyspnoea score) at other time points post pleural fluid removal(pre procedure, immediately post procedure and daily up to and 7 days)
- To determine the acceptability of incorporating surface parasternal EMG measurement as part of routine clinical practice to patients and clinicians(peri-procedural)
- Ipsilateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.(peri-procedural)
- Neural respiratory drive (as measured by surface parasternal EMG) at other time points post pleural fluid removal(pre procedure, immediately post procedure and daily up to 7 days)
- Pleural effusion characteristics as measured by thoracic ultrasound(immediately post procedure, 1 day and 7 days)
- Parasternal intercostal muscle thickness as measured by thoracic ultrasound following pleural fluid removal(peri-procedural)