Strategy for Prompt and Effective Thoracentesis in the Emergency Department: A Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 10
- 主要终点
- Time from identification of the clinical indication for thoracentesis to complete drainage
研究概览
简要总结
The SPEEDTAP-trial is a prospective, randomised, investigator-initiated, multicenter, clinical superior trial investigating two thoracentesis methods in four emergency departments (ED) in Central Denmark Region. Patients are randomised to either manual fluid removal in the ED or passively fluid drainage using gravity in the radiology department (standard of care). Primary outcome: time from clinical indication to complete drainage and 188 patients will be included. Key secondary outcomes include length of stay, ED admission to ED discharge and safety end-points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 ≥ 18 years admitted to the ED
- •Pleural effusion detected by any imaging modality (e.g., bedside ultrasound, chest x-ray, computed tomography)
- •Clinically justified need for thoracentesis ( symptomatic relief and/or define the etiology of the effusion
- •Without contraindication for thoracentesis in the emergency department (e.g., anticoagulant treatment)
排除标准
- •Life-threatening respiratory distress
- •Not able to give consent
- •Previous pleurodesis
- •Effusion does not appear free-flowing due to septations or loculations / suspected empyema
- •Prior enrollment in the trial
- •If randomization is not possible because decision to insert a pigtail catheter is made in the radiology department
结局指标
主要结局
Time from identification of the clinical indication for thoracentesis to complete drainage
时间窗: From date and time for randomization until the date and time removal of catheter, assessed up to 3 month
Time from identification of the clinical indication for thoracentesis is defined as the time patient is randomized. The time of complete drainage is defined by removal of pigtail catheter
次要结局
- Patients satisfaction(On the date of removal, assessed up until 1 month)
- Patients degree of chest discomfort (score)(from date of indication until removal of catheter, assessed up until 3 month)
- 30 days re-admission (count)(from date of discharge and up assessed until 30 days)
- Patients degree of breathlessnesss (score)(from date of indication until removal of catheter, assessed up until 3 month)
- Complications to thoracentesis (count)(from insertion of catheter and assessed up until 1 week after removal of catheter)
- Total volume drained ( ml)(from date of insertion of catheter until removal of catheter, assessed up until 3 month)
- Hospital length of stay (days)(Date of admission until date of hospital discharge, assessed up until 3 month)
- Duration of procedure (time)(from date and time for insertion until date and time for removal, assessed up until 3 month)
- 72- hour revisit from discharged (count)(from date of discharge and up until 72 hours)
- Total ED admission time (days)(From date and time for admission until date and time for ED discharge, assessed up until 1 month)