Flush, Lyse, Operate: A Pilot Trial of Step-Wise Escalation for Pleural Infection: FLO Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The goal of this observational study is to learn if saline results in improvement for patients with infection of their plerual space. The main question it aims to answer is:
What is the time to chest tube removal? Do these patients after need to escalate to fibrinolytics? Do these patients after need to escalate to surgery?
Participants will:
- Receive receive saline into their pleural space through an existing chest tube
- If they fail to improve, which will be determined by fluid size after treatment or signs of persistent infection, they will receive fibrynolytics through an existing chest tube
- If they fail to improve, which will be determined by fluid size after treatment or signs of persistent infection, they will be referred to surgery.
详细描述
Patients who require a chest tube for complicated parapneumonic effusion or empyema who meet inclusion criteria and consent, will be enrolled. An ultrasound measurement of the original effusions prior to chest tube placement will be obtained then chest tube insertion will follow as well as an additional US measurement once placed. After appropriate positioning is confirmed, there will be instillation of intrapleural saline and will be administered every 8 hours for a total of 3 days. After completion of the intrapleural saline course, the effusion will be remeasured by ultrasound. Should the effusions fail to reduce by 75% or significant septations remain, the patient will then be escalated to intrapleural tPA/DNase which will be administered every 12 hours for 3 days. After the completed course of tPA/DNase, a US will be performed, and if significant fluid remains, >50% of the original effusion or septations remain, Thoracic Surgery consultation will be placed for discussion of VATs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Complicated Parapneumonic Effusion or Empyema Requiring Thoracostomy
- •Are able to personally or have a designated medical decision maker provide consent
排除标准
- •Age < 18 years
- •Have received any intrapleural medications prior to enrolment via current chest tube
- •Have a contraindication to tPA/DNase:
- •Anticoagulation
- •Active hemorrhage
- •Allergy to tPA/DNase
- •Pregnancy
- •Are unable to personally or do not have a designated medical decision maker provide consent
研究者
Adele.E.Soutar
Pulmonary and Critical Care Fellow
Dartmouth-Hitchcock Medical Center