Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 8
- 主要终点
- Time to chest tube removal
研究概览
简要总结
Infections of the pleural space are common, and patients require antibiotics and chest drain placement to evacuate the chest from the infected fluid. Chest drains can get blocked by the drainage fluid and material. For this reason, it is thought that flushing the chest drain with saline solution, can help maintain the patency of the tube. This proposed study will evaluate the impact of regular chest drain flushing on the length of time to chest tube removal and total hospitalization as well as improvement in chest imaging and the need for additional interventions on the infected space.
详细描述
There are no randomized controlled trials (RCTs) evaluating the role of regular chest tube flushing in the setting of pleural space infection for optimal drainage and treatment outcomes. Most studies of <16 Fr catheters have used both flushing and suction to decrease the likelihood of catheter blockage and improve drainage efficiency, however, this practice has never been studied prospectively or in RCTs. Regular flushing (e.g., 20-30 ml saline every 6 h via a three-way tap) is recommended for small chest drains by the British Thoracic Society (BTS) 2010 Guidelines. This practice is followed variably by some and not used by others. Importantly, the role of this practice in successful drainage of infected fluid, and patient-centric outcomes has not been investigated. Inconsistent flushing practices confound the interpretation of therapeutic modalities (such as intrapleural tissue plasminogen activator and deoxyribonuclease therapy) success or lack thereof and limit the execution of RCTs and prospective studies of the pleural space in the setting of infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with complicated parapneumonic pleural effusion and empyema requiring chest tube placement as standard of care for inpatient management of their pleural space infection with or without intrapleural tissue plasminogen activator and deoxyribonuclease therapy
- •Age > 18 years old.
排除标准
- •Patients who have surgical tubes that can't accommodate a three-way stopcock.
- •Study subject has any disease or condition that interferes with the safe completion of the study.
- •Inability to provide informed consent.
- •Inability to undergo a chest X-ray.
- •If the managing clinician believes the chest tube will be placed for less than 24 hours.
- •Patients with an indwelling pleural catheter (IPC)
研究组 & 干预措施
Saline Intervention Arm
Patient will receive 20 mL sterile saline flushes into their catheter by study team members every 6 ± 2 hours. If patients are receiving intrapleural tissue plasminogen activator and deoxyribonuclease therapy, each treatment will be considered one flush.
干预措施: Saline Flush (Other)
No Intervention Arm
Patient will receive a saline flush as needed, to restore patency of a chest tube considered blocked. No routine flushes will be administered.
结局指标
主要结局
Time to chest tube removal
时间窗: up to 3 months
The investigators will assess the time from randomization (within 24 hours of chest tube placement) until time to chest tube removal
次要结局
- Length of hospitalization(up to 365 days)
- Radiographic improvement as evidenced by chest x-ray at the time of chest tube placement compared to the time of removal(through study completion, an average of 3 months)
- Additional surgical procedures for the management of pleural space infection(an average of 3 months)
- Complications(through study completion, an average of 3 months)
研究者
Samira Shojaee
Associate Professor of Medicine
Vanderbilt University Medical Center