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临床试验/NCT01775657
NCT01775657已完成不适用

Digital Versus Analog Pleural Drainage Following Pulmonary Resection

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
176
试验地点
2
主要终点
Overall length of hospitalization

研究概览

简要总结

This study will evaluate the impact of continuous, digital pulmonary air leak monitoring on the duration of pleural drainage after lung resection in patients with and without a pulmonary air leak on postoperative day 1.

Patients undergoing pulmonary resection who fit the inclusion criteria will be identified pre-operatively. Patients within two groups (air leak and no air leak) will be randomized to receive either the analogue system or the digital system. Both systems are approved for use in hospitals by Health Canada. There will be 88 patients in each air leak group.

Hypothesis: Continuous, quantitative monitoring of PAL following lung resection leads to an improvement in primary outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Elective pulmonary resection (i.e. wedge, segmentectomy, lobectomy, bilobectomy) for benign or neoplastic disease

排除标准

  • Development of tension pneumothorax
  • Pneumonectomy
  • Patient no longer within planned randomization window
  • Plan to remove or removal of all chest drains within 36 hours of surgery
  • Inability to provide informed consent
  • Age < 18 years
  • Patient was previously randomized following pulmonary resection

结局指标

主要结局

Overall length of hospitalization

时间窗: Up to 5 days post-op (average)

次要结局

  • Time to first pleural drain removal(Over 24 hours post-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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