Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
赞助:
Rennes University Hospital
合作者:
信息的提供 (责任方):
，
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 27, 2018 | ||
| 首次发布日期e ICMJE | October 1, 2018 | ||
| 最后更新发布日期 | October 1, 2018 | ||
| 预计研究开始日期 ICMJE | June 2019 | ||
| 预计主要完成日期 | June 2022 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Successful patient rates of ambulatory care[ Time Frame: Day 4 ] |
||
| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
|
||
| 描述性信息 | |||
| 简略标题 ICMJE | Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study | ||
| 正式标题 ICMJE | Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study | ||
| 简要概况 | The management of spontaneous large pneumothorax is not consensual. The current management involves the establishment of a Fuhrman catheter and an outpatient monitoring in pneumology consultation. Another alternative is widespread: simple exsufflation. However, no study has looked at the direct prospective comparison of these 2 treatments. |
||
| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
||
| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
|
||
| 研究工具 |
|
||
| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
188 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | June 2023 | ||
| 预计主要完成日期 | June 2022 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - First episode of primary spontaneous pneumothorax wide according to the criteria Exclusion Criteria: | ||
| 性别 |
|
||
| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
||
| IPD 共享声明 |
|
||
| 责任方 | ， | ||
| 研究赞助商 ICMJE | Rennes University Hospital | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
|
||
| PRS 账户 | |||
| 验证日期 | September 2018 | ||
|
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
|||
请使用微信扫码报名
京公网安备 11010102003638号