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临床试验/NCT05424120
NCT05424120已完成不适用

Thoracentesis Quality Improvement (QI) Study

University of Minnesota2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2022年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
2
主要终点
Pain and dyspnea scores- Post-fluid

研究概览

简要总结

Researchers will compare 3 standard of care methods of pleural fluid drainage during therapeutic thoracentesis. Patients are randomized to manual aspiration, vacuum bottle drainage or wall suction methods. Primary outcome is procedural time with secondary outcomes of pain and dyspnea scores.

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

入选标准

  • Evidence of pleural effusion on imaging
  • Clinical indication for thoracentesis

排除标准

  • Standard contraindication for thoracentesis procedure
  • Patients on positive pressure ventilation
  • Patients who have opted out of research in EPIC

结局指标

主要结局

Pain and dyspnea scores- Post-fluid

时间窗: Through study completion, an average of 24 hours

Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)

Pain and dyspnea scores- 5m post

时间窗: 5 minutes post-procedure

Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)

Pain and dyspnea scores- 24h post

时间窗: 24 hours post-procedure

Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)

Procedural time to 500mL

时间窗: Through study completion, an average of 24 hours

Time to pleural fluid drainage from initiation of therapeutic drainage to 500mL

Pain and dyspnea scores- Baseline

时间窗: Immediately prior to starting the thoracentesis

Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)

Pain and dyspnea scores- Cath

时间窗: Through study completion, an average of 24 hours

Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)

Pain and dyspnea scores- Post-cath

时间窗: Immediately after removing the thoracentesis catheter

Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)

Procedural time to 750mL

时间窗: Through study completion, an average of 24 hours

Time to pleural fluid drainage from initiation of therapeutic drainage to 750mL

Procedural time to 1L

时间窗: Through study completion, an average of 24 hours

Time to pleural fluid drainage from initiation of therapeutic drainage to 1L

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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