Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Difference between time to next thoracentesis scheduled by the pulmonologist and patient respectively versus time to patient-reported need for thoracentesis
研究概览
简要总结
Recurrent fluid surrounding the lungs is associated with poor quality of life, the main symptom being dyspnea. These patients are in need of recurrent removal of the fluid using drainage. The mechanism causing dyspnea is not fully understood.
By using ultrasound to evaluate the movement of the diaphragm before and after removal of fluid and the patients symptoms before removal of fluid and until next removal the research group aims to clarify the temporal development in symptoms and the role of the diaphragm.
The researchers will also evaluate the ability of the pulmonologist and patient to predict when the patient will need the next removal of fluid in patients with recurrent unilateral pleural effusion.
详细描述
Recurrent pleural effusion (PE) is associated with impaired quality of life, the main symptom being dyspnea. The mechanisms causing dyspnea in PE is not fully understood. These patients are in need of recurrent therapeutic thoracentesis.
By evaluating the movement of diaphragma before and after thoracentesis and measure the patients symptoms before thoracentesis and until the next thoracentesis the researchers aim to clarify the temporal development in symptoms and the role of the diaphragm.
The researchers will also evaluate the ability of the pulmonologist and patient to predict when the patient will need the next therapeutic thoracentesis in patients with recurrent unilateral pleural effusion.
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.
- •Unilateral pleural effusion.
- •A minimum of two thoracentesis prior to inclusion.
- •Patients must be able to give informed consent.
排除标准
- •Bilateral pleural effusions.
- •Inability to understand written or spoken Danish.
结局指标
主要结局
Difference between time to next thoracentesis scheduled by the pulmonologist and patient respectively versus time to patient-reported need for thoracentesis
时间窗: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
Measured in days. The patients and pulmonologists scheduling is recorded on a questionnaire at the day of first thoracentesis, after the procedure
次要结局
- Fluid removed at the second study-thoracentesis(At the day of the the second thoracentesis, immediately after end procedure)
- Patients experienced well being(At day 1 immediately prior to and immediately after thoracentesis)
- Patients perception of dyspnea(At day 1 immediately prior to and immediately after thoracentesis.)
- Correlation between amount of pleural fluid removed at the first study-thoracentesis (outcome 6) and symptoms (well being and dyspnea, outcome 4 and 5) until next thoracentesis.(At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.)
- Patient experienced dyspnea until next thoracentesis(At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.)
- Patient experienced well being until next thoracentesis(At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.)
- Correlation between well being and dyspnea (outcome 2, 3 and 4) and findings on lung ultrasound before and after completed thoracentesis(At day 1 immediately after ended procedure)
- Fluid removed at the first study-thoracentesis(At day 1, immediately after end of procedure)
- Correlation between patient's symptoms (well being and dyspnea, outcome 4, 5and 6) and time to next thoracentesis(At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.)
- Correlation between time in between thoracentesis and amount of fluid drained at the following thoracentesis(thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.)